Trial Outcomes & Findings for A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab (NCT NCT01495000)

NCT ID: NCT01495000

Last Updated: 2014-02-07

Results Overview

Bone mineral density (BMD) at the lumbar spine was measured by the dual-energy x-ray absorptiometry (DXA) scanner. The mean percent change from Baseline in BMD was calculated as: (value at Month 6 minus Baseline value) \* 100 / Baseline value. Analysis was performed using an Analysis of Covariance (ANCOVA) model with terms for treatment and baseline BMD at the lumbar spine (as a continuous covariate).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 250 participants
• Primary outcome timeframe: Baseline and Month 6
• Results posted on: 2014-02-07

Participant Flow

The study consisted of a Screening Phase of up to 2.5 months and a 6-month Double-blind Treatment Phase. A total of 551 participants (par.) were screened; 303 par. were screen failures, and 250 par. were randomized (2 par. were considered to be screen failures; however, these par. were randomized, 1 to each treatment group).

Participant milestones

Measure	Denosumab 60 mg Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units \[IU\]).	Placebo Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
Overall Study STARTED	124	126
Overall Study COMPLETED	111	114
Overall Study NOT COMPLETED	13	12

Reasons for withdrawal

Measure	Denosumab 60 mg Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units \[IU\]).	Placebo Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
Overall Study Lost to Follow-up	2	2
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	10	10

Baseline Characteristics

A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab

Baseline characteristics by cohort

Measure	Denosumab 60 mg n=124 Participants Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units \[IU\]).	Placebo n=126 Participants Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).	Total n=250 Participants Total of all reporting groups
Age, Continuous	62.6 Years STANDARD_DEVIATION 5.10 • n=5 Participants	62.6 Years STANDARD_DEVIATION 4.85 • n=7 Participants	62.6 Years STANDARD_DEVIATION 4.96 • n=5 Participants
Sex: Female, Male Female	124 Participants n=5 Participants	126 Participants n=7 Participants	250 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	124 participants n=5 Participants	126 participants n=7 Participants	250 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Month 6

Population: Intent-to-Treat Efficacy (ITTE) Population: all randomized participants who received one dose of study medication, and who had a Baseline measure and at least one post-Baseline efficacy measure during the Double-blind Treatment Phase. Only participants with BMD values at both Baseline and Month 6 were analyzed.

Bone mineral density (BMD) at the lumbar spine was measured by the dual-energy x-ray absorptiometry (DXA) scanner. The mean percent change from Baseline in BMD was calculated as: (value at Month 6 minus Baseline value) * 100 / Baseline value. Analysis was performed using an Analysis of Covariance (ANCOVA) model with terms for treatment and baseline BMD at the lumbar spine (as a continuous covariate).

Outcome measures

Measure	Denosumab 60 mg n=100 Participants Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units \[IU\]).	Placebo n=105 Participants Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
Mean Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 6	4.26 percent change Standard Error 0.413	1.20 percent change Standard Error 0.403

SECONDARY outcome

Timeframe: Baseline and Month 6

Population: ITTE Population. Only participants with BMD values at both Baseline and Month 6 were analyzed.

BMD at the total hip, femoral neck, and trochanter was measured by the DXA scanner. The mean percent change from Baseline in BMD was calculated as: (value at Month 6 minus Baseline value) * 100 / Baseline value. Analysis was performed using an ANCOVA model with terms for treatment and corresponding Baseline BMD (as a continuous covariate).

Outcome measures

Measure	Denosumab 60 mg n=87 Participants Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units \[IU\]).	Placebo n=86 Participants Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
Mean Percent Change From Baseline in BMD at the Total Hip, Femoral Neck, and Trochanter at Month 6 Total Hip	2.02 percent change Standard Error 0.270	0.32 percent change Standard Error 0.271
Mean Percent Change From Baseline in BMD at the Total Hip, Femoral Neck, and Trochanter at Month 6 Femoral Neck	2.69 percent change Standard Error 0.407	0.40 percent change Standard Error 0.409
Mean Percent Change From Baseline in BMD at the Total Hip, Femoral Neck, and Trochanter at Month 6 Trochanter	2.49 percent change Standard Error 0.366	0.69 percent change Standard Error 0.368

SECONDARY outcome

Timeframe: Baseline; Months 1, 3, and 6

Population: ITTE Population. Only participants with s-CTX and s-PINP values at both Baseline and Months 1, 3, and 6 were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects the entire ITTE Population.

Blood samples were collected for the measurement of s-CTx and s-PINP, which are used as biomarkers of bone resorption and formation, respectively. The median percent change from Baseline in s-CTX and s-PINP markers at Months 1, 3, and 6 was calculated as: (post-Baseline value minus Baseline value) * 100 / Baseline value.

Outcome measures

Measure	Denosumab 60 mg n=121 Participants Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units \[IU\]).	Placebo n=123 Participants Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
Median Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum Procollagen Type IN Propeptide (s-PINP) Markers at Months 1, 3, and 6 s-CTx, Month 6, n=105, 113	-62.5 percent change Interval -77.6 to -42.86	-28.82 percent change Interval -47.33 to -1.15
Median Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum Procollagen Type IN Propeptide (s-PINP) Markers at Months 1, 3, and 6 s-CTx, Month 1, n=112, 121	-80.61 percent change Interval -87.42 to -65.04	-17.01 percent change Interval -40.03 to 6.93
Median Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum Procollagen Type IN Propeptide (s-PINP) Markers at Months 1, 3, and 6 s-CTx, Month 3, n=107, 113	-82.43 percent change Interval -87.5 to -66.54	-18.97 percent change Interval -44.25 to 3.56
Median Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum Procollagen Type IN Propeptide (s-PINP) Markers at Months 1, 3, and 6 s-PINP, Month 1, n=110, 120	-34.55 percent change Interval -50.0 to -21.74	-13.62 percent change Interval -23.94 to -2.21
Median Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum Procollagen Type IN Propeptide (s-PINP) Markers at Months 1, 3, and 6 s-PINP, Month 3, n=107, 111	-78.08 percent change Interval -84.13 to -65.38	-27.87 percent change Interval -42.68 to -1.75
Median Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum Procollagen Type IN Propeptide (s-PINP) Markers at Months 1, 3, and 6 s-PINP, Month 6, n=104, 113	-63.41 percent change Interval -76.5 to -53.85	-25.81 percent change Interval -41.79 to 0.0

SECONDARY outcome

Timeframe: From Baseline up to Month 6

Population: ITT Population: all participants who received one dose of study medication

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury with hyperbilirubinaemia. Medical or scientific judgment was to have been exercised in other important medical events. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.

Outcome measures

Measure	Denosumab 60 mg n=124 Participants Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units \[IU\]).	Placebo n=126 Participants Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Any AE	38 participants	47 participants
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Any SAE	1 participants	3 participants

SECONDARY outcome

Timeframe: Baseline; Months 1, 3, and 6

Population: ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.

Vital sign values of potential clinical concern were defined as: change in heart rate >30 beats per minutes (bpm), change in systolic blood pressure (SBP) >30 millimeters of mercury (mmHg), and change in diastolic blood pressure (DBP) >20 mmHg. The number of participants with post-Baseline vital sign values of potential clinical concern who did not have values of potential clinical concern at Baseline are summarized. If the change from Baseline is a decrease greater than the threshold, it is categorized as "low." If the change from Baseline is an increase greater than the threshold, it is categorized ad "high."

Outcome measures

Measure	Denosumab 60 mg n=124 Participants Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units \[IU\]).	Placebo n=126 Participants Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Months 1, 3, and 6 DBP, Month 1: High, n=122, 125	1 participants	2 participants
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Months 1, 3, and 6 DBP, Month 1: Low, n=122, 125	1 participants	4 participants
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Months 1, 3, and 6 DBP, Month 3: High, n=117, 120	2 participants	0 participants
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Months 1, 3, and 6 DBP, Month 3: Low, n=117, 120	0 participants	2 participants
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Months 1, 3, and 6 DBP, Month 6: Low, n=111, 114	0 participants	3 participants
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Months 1, 3, and 6 SBP, Month 1: Low, n=122, 125	1 participants	2 participants
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Months 1, 3, and 6 SBP, Month 3: High, n=117, 120	1 participants	1 participants
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Months 1, 3, and 6 SBP, Month 3: Low, n=117, 120	1 participants	3 participants
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Months 1, 3, and 6 SBP, Month 6: Low, n=111, 114	2 participants	3 participants
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Months 1, 3, and 6 Heart Rate, Month 3: Low, n=117, 120	0 participants	1 participants

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.

The number of participants with laboratory parameter values of potential clinical concern at Month 6 are summarized. The following are the laboratory values of potential clinical concern: alkaline phosphatase, High: >375 units/Liter (L); aspartate aminotransferase, High: >165 units/L; creatinine, High: >159 micromoles (µmol)/L; glucose, Low: <3 millimoles (mmol)/L; hematocrit, Low: <0.325; hemoglobin, Low: <91grams/L; phosphorus, High: >1.723 mmol/L; potassium, High: >6.3 mmol/L; sodium, Low: <130 mmol/L; total neutrophils, Low: <0.9 10^9 cells (GI)/L; blood urea nitrogen (BUN), High: >21mmol/L; uric acid, High: 654 µmol/L.

Outcome measures

Measure	Denosumab 60 mg n=124 Participants Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units \[IU\]).	Placebo n=126 Participants Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at Month 6 Alkaline phosphatase: High, n=107, 114	0 participants	1 participants
Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at Month 6 Aspartate aminotransferase: High, n=107, 113	1 participants	0 participants
Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at Month 6 Creatinine: High, n=107, 114	1 participants	1 participants
Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at Month 6 Glucose: Low, n=107, 114	1 participants	0 participants
Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at Month 6 Hematocrit: Low, n=106, 111	1 participants	1 participants
Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at Month 6 Hemoglobin: Low, n=106, 111	2 participants	3 participants
Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at Month 6 Inorganic Phosphorus: High, n=107, 114	0 participants	1 participants
Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at Month 6 Potassium: High, n=107, 113	1 participants	0 participants
Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at Month 6 Sodium: Low, n=107, 114	0 participants	1 participants
Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at Month 6 Total Neutrophils: Low, n=104, 107	0 participants	2 participants
Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at Month 6 Urea/BUN: High, n=107, 114	0 participants	1 participants
Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at Month 6 Uric Acid: High, n=107, 114	0 participants	1 participants

SECONDARY outcome

Timeframe: Baseline and Month 6

Population: ITT Population. Only participants available at the specified time points were analyzed.

Blood samples were collected for the measurement of albumin/globulin ratio and BUN/creatinine ratio values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.

Outcome measures

Measure	Denosumab 60 mg n=106 Participants Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units \[IU\]).	Placebo n=114 Participants Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6 Albumin/globulin ratio	0.025 ratio Standard Deviation 0.1446	0.018 ratio Standard Deviation 0.1518
Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6 BUN/creatinine ratio	-5.896 ratio Standard Deviation 18.0195	-1.860 ratio Standard Deviation 19.8400

SECONDARY outcome

Timeframe: Baseline and Month 6

Population: ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.

Blood samples were collected for the measurement of albumin, hemoglobin, mean corpuscle hemoglobin concentration, and total protein values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.

Outcome measures

Measure	Denosumab 60 mg n=124 Participants Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units \[IU\]).	Placebo n=126 Participants Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin Concentration (Conc.), and Total Protein at Month 6 Albumin, n=106, 114	0.689 grams per liter (g/L) Standard Deviation 2.4470	0.746 grams per liter (g/L) Standard Deviation 2.9020
Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin Concentration (Conc.), and Total Protein at Month 6 Hemoglobin, n=106, 107	2.236 grams per liter (g/L) Standard Deviation 6.2891	1.925 grams per liter (g/L) Standard Deviation 8.4927
Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin Concentration (Conc.), and Total Protein at Month 6 Mean corpuscle hemoglobin conc., n=106, 107	2.321 grams per liter (g/L) Standard Deviation 9.8653	1.607 grams per liter (g/L) Standard Deviation 10.0196
Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin Concentration (Conc.), and Total Protein at Month 6 Total protein, n=106, 114	0.585 grams per liter (g/L) Standard Deviation 3.8219	0.886 grams per liter (g/L) Standard Deviation 4.1621

SECONDARY outcome

Timeframe: Baseline and Month 6

Population: ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.

Blood samples were collected for the measurement of alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatinine kinase, gamma glutamyl transferase, and lactate dehydrogenase values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.

Outcome measures

Measure	Denosumab 60 mg n=124 Participants Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units \[IU\]).	Placebo n=126 Participants Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Month 6 Alkaline phosphatase, n=106, 114	-18.179 International units per liter (IU/L) Standard Deviation 25.0207	-3.684 International units per liter (IU/L) Standard Deviation 41.4420
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Month 6 Alanine amino transferase, n=106, 114	2.481 International units per liter (IU/L) Standard Deviation 10.2421	0.035 International units per liter (IU/L) Standard Deviation 15.6640
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Month 6 Aspartate amino transferase, 106, 113	2.755 International units per liter (IU/L) Standard Deviation 10.9465	-0.965 International units per liter (IU/L) Standard Deviation 16.9226
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Month 6 Creatinine kinase, n=106, 114	6.170 International units per liter (IU/L) Standard Deviation 51.2968	11.175 International units per liter (IU/L) Standard Deviation 63.0331
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Month 6 Gamma glutamyl transferase, n=106, 114	2.915 International units per liter (IU/L) Standard Deviation 12.8346	-0.754 International units per liter (IU/L) Standard Deviation 13.8433
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Month 6 Lactate dehydrogenase, n=106, 113	2.764 International units per liter (IU/L) Standard Deviation 25.2811	0.434 International units per liter (IU/L) Standard Deviation 36.7389

SECONDARY outcome

Timeframe: Baseline and Month 6

Population: ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.

Blood samples were collected for the measurement of basophil, eosinophil, lymphocyte, monocyte, segmented neutrophil, total neutrophil, platelet count, and white blood cell count values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.

Outcome measures

Measure	Denosumab 60 mg n=124 Participants Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units \[IU\]).	Placebo n=126 Participants Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Total Neutrophils, Platelet Count, and White Blood Cell Count Month 6 Basophils, n=104, 103	0.001 10^9 cells per liter (GI/L) Standard Deviation 0.0221	-0.001 10^9 cells per liter (GI/L) Standard Deviation 0.0262
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Total Neutrophils, Platelet Count, and White Blood Cell Count Month 6 Eosinophils, n=104, 103	-0.076 10^9 cells per liter (GI/L) Standard Deviation 0.2794	-0.001 10^9 cells per liter (GI/L) Standard Deviation 0.3414
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Total Neutrophils, Platelet Count, and White Blood Cell Count Month 6 Lymphocytes, n=104, 103	-0.065 10^9 cells per liter (GI/L) Standard Deviation 0.6044	-0.056 10^9 cells per liter (GI/L) Standard Deviation 0.7476
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Total Neutrophils, Platelet Count, and White Blood Cell Count Month 6 Monocytes, n=104, 103	0.000 10^9 cells per liter (GI/L) Standard Deviation 0.1204	0.032 10^9 cells per liter (GI/L) Standard Deviation 0.1727
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Total Neutrophils, Platelet Count, and White Blood Cell Count Month 6 Segmented neutrophils, n=104, 103	-0.290 10^9 cells per liter (GI/L) Standard Deviation 1.6142	-0.129 10^9 cells per liter (GI/L) Standard Deviation 1.7405
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Total Neutrophils, Platelet Count, and White Blood Cell Count Month 6 Total neutrophils, n=104, 103	-0.297 10^9 cells per liter (GI/L) Standard Deviation 1.6099	-0.135 10^9 cells per liter (GI/L) Standard Deviation 1.7343
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Total Neutrophils, Platelet Count, and White Blood Cell Count Month 6 Platelet count, n=103, 105	3.117 10^9 cells per liter (GI/L) Standard Deviation 38.5322	7.533 10^9 cells per liter (GI/L) Standard Deviation 36.5761
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Total Neutrophils, Platelet Count, and White Blood Cell Count Month 6 White blood cell count, n=104, 103	-0.436 10^9 cells per liter (GI/L) Standard Deviation 1.6614	-0.160 10^9 cells per liter (GI/L) Standard Deviation 1.7629

SECONDARY outcome

Timeframe: Baseline and Month 6

Population: ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.

Blood samples were collected for the measurement of direct bilirubin, indirect bilirubin, total bilirubin, creatinine, and uric acid values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.

Outcome measures

Measure	Denosumab 60 mg n=124 Participants Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units \[IU\]).	Placebo n=126 Participants Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Month 6 Direct bilirubin, n=105, 112	0.152 micromoles per liter (UMOL/L) Standard Deviation 1.1667	0.089 micromoles per liter (UMOL/L) Standard Deviation 1.2122
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Month 6 Indirect bilirubin, n=105, 112	0.210 micromoles per liter (UMOL/L) Standard Deviation 2.7305	-0.054 micromoles per liter (UMOL/L) Standard Deviation 2.2050
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Month 6 Total bilirubin, n=106, 114	0.358 micromoles per liter (UMOL/L) Standard Deviation 2.8659	0.000 micromoles per liter (UMOL/L) Standard Deviation 2.2102
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Month 6 Creatinine, n=106, 114	2.337 micromoles per liter (UMOL/L) Standard Deviation 11.8458	3.041 micromoles per liter (UMOL/L) Standard Deviation 13.1471
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Month 6 Uric acid, n=106, 114	-2.642 micromoles per liter (UMOL/L) Standard Deviation 60.6677	-6.316 micromoles per liter (UMOL/L) Standard Deviation 61.9058

SECONDARY outcome

Timeframe: Baseline and Month 6

Population: ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.

Blood samples were collected for the measurement of calcium corrected, calcium, chloride, glucose, potassium, magnesium, sodium, phosphorus inorganic, triglyceride, urea/BUN, and VLDL cholesterol calculation values. Change from Baseline was calcualted as the Month 6 value minus the Baseline value.

Outcome measures

Measure	Denosumab 60 mg n=124 Participants Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units \[IU\]).	Placebo n=126 Participants Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, and Very Low-density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 Calcium corrected, n=12, 24	0.015 millimoles per liter (MMOL/L) Standard Deviation 0.0573	0.008 millimoles per liter (MMOL/L) Standard Deviation 0.0755
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, and Very Low-density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 Calcium, n=106, 113	0.012 millimoles per liter (MMOL/L) Standard Deviation 0.1194	0.033 millimoles per liter (MMOL/L) Standard Deviation 0.1069
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, and Very Low-density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 Chloride, n=106, 114	-0.802 millimoles per liter (MMOL/L) Standard Deviation 3.0376	-0.895 millimoles per liter (MMOL/L) Standard Deviation 3.0552
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, and Very Low-density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 Glucose, n=106, 113	-0.571 millimoles per liter (MMOL/L) Standard Deviation 2.2401	-0.303 millimoles per liter (MMOL/L) Standard Deviation 2.6346
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, and Very Low-density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 Potassium, n=106, 113	0.140 millimoles per liter (MMOL/L) Standard Deviation 0.4581	0.158 millimoles per liter (MMOL/L) Standard Deviation 0.4118
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, and Very Low-density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 Magnesium, n=106, 114	0.009 millimoles per liter (MMOL/L) Standard Deviation 0.0718	0.009 millimoles per liter (MMOL/L) Standard Deviation 0.0614
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, and Very Low-density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 Sodium, n=106, 114	-0.472 millimoles per liter (MMOL/L) Standard Deviation 2.2979	-0.395 millimoles per liter (MMOL/L) Standard Deviation 2.5921
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, and Very Low-density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 Phosphorus inorganic, n=106, 114	-0.052 millimoles per liter (MMOL/L) Standard Deviation 0.2047	-0.012 millimoles per liter (MMOL/L) Standard Deviation 0.1674
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, and Very Low-density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 Triglycerides, n=106, 114	-0.305 millimoles per liter (MMOL/L) Standard Deviation 0.7413	-0.263 millimoles per liter (MMOL/L) Standard Deviation 0.8433
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, and Very Low-density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 Urea/BUN, n=106, 114	-0.283 millimoles per liter (MMOL/L) Standard Deviation 1.1423	0.114 millimoles per liter (MMOL/L) Standard Deviation 2.2032
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, and Very Low-density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 VLDL cholesterol calculation, n=103, 109	-0.131 millimoles per liter (MMOL/L) Standard Deviation 0.3178	-0.105 millimoles per liter (MMOL/L) Standard Deviation 0.3504

SECONDARY outcome

Timeframe: Baseline and Month 6

Population: ITT Population. Only participants available at the specified time points were analyzed.

Blood samples were collected for the measurement of hematocrit values. Change from Baseline was calculated as the Month 6 value minuse the Baseline value.

Outcome measures

Measure	Denosumab 60 mg n=106 Participants Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units \[IU\]).	Placebo n=107 Participants Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
Change From Baseline in Hematocrit at Month 6	0.004 proportion of RBCs in blood Standard Deviation 0.0204	0.004 proportion of RBCs in blood Standard Deviation 0.0264

SECONDARY outcome

Timeframe: Baseline and Month 6

Population: ITT Population. Only participants available at the specified time points were analyzed.

Blood samples were collected for the measurement of hemoglobin values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.

Outcome measures

Measure	Denosumab 60 mg n=106 Participants Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units \[IU\]).	Placebo n=107 Participants Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
Change From Baseline in Mean Corpuscle Hemoglobin at Month 6	0.407 picograms Standard Deviation 0.8613	0.260 picograms Standard Deviation 1.2787

SECONDARY outcome

Timeframe: Baseline and Month 6

Population: ITT Population. Only participants available at the specified time points were analyzed.

Blood samples were collected for the measurement of mean corpuscular volume values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.

Outcome measures

Measure	Denosumab 60 mg n=106 Participants Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units \[IU\]).	Placebo n=107 Participants Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
Change From Baseline in Mean Corpuscular Volume at Month 6	0.623 femtoliters Standard Deviation 2.9775	0.327 femtoliters Standard Deviation 3.5309

SECONDARY outcome

Timeframe: Baseline and Month 6

Population: ITT Population. Only participants available at the specified time points were analyzed.

Blood samples were collected for the measurement of red blood cell count values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.

Outcome measures

Measure	Denosumab 60 mg n=106 Participants Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units \[IU\]).	Placebo n=107 Participants Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
Change From Baseline in Red Blood Cell Count at Month 6	0.016 10^12 cells per liter (TI/L) Standard Deviation 0.2575	0.034 10^12 cells per liter (TI/L) Standard Deviation 0.3034

SECONDARY outcome

Timeframe: Baseline and Month 6

Population: ITT Population. Only participants available at the specified time points were analyzed.

Blood samples were collected for the measurement of red cell distribution width values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.

Outcome measures

Measure	Denosumab 60 mg n=106 Participants Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units \[IU\]).	Placebo n=107 Participants Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
Change From Baseline in Red Cell Distribution Width at Month 6	0.065 percentage Standard Deviation 1.2126	-0.121 percentage Standard Deviation 1.2735

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population. Only participants available at the specified time point were analyzed.

The number of participants with positive and negative results for both neutralizing antibodies to denosumab and for binding antibodies to denosumab at Month 6 are summarized.

Outcome measures

Measure	Denosumab 60 mg n=110 Participants Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units \[IU\]).	Placebo n=114 Participants Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 6 Neutralizing antibodies, n=0, 0	NA participants Participants were only to have been analyzed for neutralizing antibodies in the event that they were positive for binding antibodies. Because no participants were positive for binding antibodies, no analysis was conducted for neutralizing antibodies.	NA participants Participants were only to have been analyzed for neutralizing antibodies in the event that they were positive for binding antibodies. Because no participants were positive for binding antibodies, no analysis was conducted for neutralizing antibodies.
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 6 Binding antibodies, Positive, n=110, 114	0 participants	0 participants
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 6 Binding antibodies, Negative, n=110, 114	110 participants	114 participants

Adverse Events

Denosumab 60 mg

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Denosumab 60 mg n=124 participants at risk Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units \[IU\]).	Placebo n=126 participants at risk Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
Vascular disorders Hypotension	0.00% 0/124 • SAEs (serious adverse events) and non-serious AEs were collected from the start of study medication through the study period (6-month post-dose) (up to Study Week 43). AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who received one dose of study medication.	0.79% 1/126 • SAEs (serious adverse events) and non-serious AEs were collected from the start of study medication through the study period (6-month post-dose) (up to Study Week 43). AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who received one dose of study medication.
Vascular disorders Varicose vein ruptured	0.00% 0/124 • SAEs (serious adverse events) and non-serious AEs were collected from the start of study medication through the study period (6-month post-dose) (up to Study Week 43). AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who received one dose of study medication.	0.79% 1/126 • SAEs (serious adverse events) and non-serious AEs were collected from the start of study medication through the study period (6-month post-dose) (up to Study Week 43). AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who received one dose of study medication.
Eye disorders Cataract nuclear	0.81% 1/124 • SAEs (serious adverse events) and non-serious AEs were collected from the start of study medication through the study period (6-month post-dose) (up to Study Week 43). AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who received one dose of study medication.	0.00% 0/126 • SAEs (serious adverse events) and non-serious AEs were collected from the start of study medication through the study period (6-month post-dose) (up to Study Week 43). AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who received one dose of study medication.
General disorders Asthenia	0.00% 0/124 • SAEs (serious adverse events) and non-serious AEs were collected from the start of study medication through the study period (6-month post-dose) (up to Study Week 43). AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who received one dose of study medication.	0.79% 1/126 • SAEs (serious adverse events) and non-serious AEs were collected from the start of study medication through the study period (6-month post-dose) (up to Study Week 43). AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who received one dose of study medication.
Infections and infestations Liver abscess	0.00% 0/124 • SAEs (serious adverse events) and non-serious AEs were collected from the start of study medication through the study period (6-month post-dose) (up to Study Week 43). AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who received one dose of study medication.	0.79% 1/126 • SAEs (serious adverse events) and non-serious AEs were collected from the start of study medication through the study period (6-month post-dose) (up to Study Week 43). AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who received one dose of study medication.
Investigations Hepatic enzyme increased	0.00% 0/124 • SAEs (serious adverse events) and non-serious AEs were collected from the start of study medication through the study period (6-month post-dose) (up to Study Week 43). AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who received one dose of study medication.	0.79% 1/126 • SAEs (serious adverse events) and non-serious AEs were collected from the start of study medication through the study period (6-month post-dose) (up to Study Week 43). AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who received one dose of study medication.

Other adverse events

Measure	Denosumab 60 mg n=124 participants at risk Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units \[IU\]).	Placebo n=126 participants at risk Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
Infections and infestations Upper respiratory tract infection	6.5% 8/124 • SAEs (serious adverse events) and non-serious AEs were collected from the start of study medication through the study period (6-month post-dose) (up to Study Week 43). AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who received one dose of study medication.	2.4% 3/126 • SAEs (serious adverse events) and non-serious AEs were collected from the start of study medication through the study period (6-month post-dose) (up to Study Week 43). AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who received one dose of study medication.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER