Trial Outcomes & Findings for Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263) (NCT NCT00729651)

NCT ID: NCT00729651

Last Updated: 2024-04-23

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

343 participants

Primary outcome timeframe

16 weeks

Results posted on

2024-04-23

Participant Flow

17 centers participated in this study (11 - Medical Center of the University, 7 - General Hospital). FPE(First patient enrolled) : March-2008, FPI(First patient in) : April-2008, LPO(Last patient out) : April-2009.

Participant milestones

Participant milestones
Measure	Fosamax Plus D Once weekly Fosamax plus D tablet \[Alendronate sodium 70 mg/Cholecalciferol 5600 IU\] + once daily calcium formulation \[500 mg/day\]), 16 weeks	Fosamax Once weekly Fosamax 70 mg tablet \[Alendronate sodium 70 mg\] + once daily calcium formulation \[500 mg/day\]), 16 weeks
Overall Study STARTED	173	170
Overall Study COMPLETED	154	152
Overall Study NOT COMPLETED	19	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Fosamax Plus D Once weekly Fosamax plus D tablet \[Alendronate sodium 70 mg/Cholecalciferol 5600 IU\] + once daily calcium formulation \[500 mg/day\]), 16 weeks	Fosamax Once weekly Fosamax 70 mg tablet \[Alendronate sodium 70 mg\] + once daily calcium formulation \[500 mg/day\]), 16 weeks
Overall Study Withdrawal by Subject	5	6
Overall Study Lost to Follow-up	5	4
Overall Study Protocol Violation	0	1
Overall Study Adverse Event	7	3
Overall Study Visit 3, 25 OHD level ≤9 ng/mL	0	4
Overall Study Subject's private reason	2	0

Baseline Characteristics

Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fosamax Plus D n=173 Participants Once weekly Fosamax plus D tablet \[Alendronate sodium 70 mg/Cholecalciferol 5600 IU\] + once daily calcium formulation \[500 mg/day\]), 16 weeks	Fosamax n=170 Participants Once weekly Fosamax 70 mg tablet \[Alendronate sodium 70 mg\] + once daily calcium formulation \[500 mg/day\]), 16 weeks	Total n=343 Participants Total of all reporting groups
Age, Continuous	64.59 years STANDARD_DEVIATION 7.09 • n=5 Participants	65.31 years STANDARD_DEVIATION 7.62 • n=7 Participants	64.94 years STANDARD_DEVIATION 7.36 • n=5 Participants
Age, Customized <=44 years of age	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Age, Customized 45-49 years of age	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Age, Customized 50-59 years of age	47 participants n=5 Participants	43 participants n=7 Participants	90 participants n=5 Participants
Age, Customized 60-69 years of age	85 participants n=5 Participants	73 participants n=7 Participants	158 participants n=5 Participants
Age, Customized 70-79 years of age	37 participants n=5 Participants	51 participants n=7 Participants	88 participants n=5 Participants
Age, Customized >=80 years of age	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Sex: Female, Male Female	173 Participants n=5 Participants	170 Participants n=7 Participants	343 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Patients with/without Vitamin D deficiency With Vitamin D deficiency at baseline	57 participants n=5 Participants	56 participants n=7 Participants	113 participants n=5 Participants
Patients with/without Vitamin D deficiency Without Vitamin D deficiency at baseline	116 participants n=5 Participants	114 participants n=7 Participants	230 participants n=5 Participants
T-score classification by inclusion criteria: A fracture in spine Lumbar 1-4 and T-score ≤ -2.0] A fracture in spine Lumbar 1-4 and T-score ≤ -2.0	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
T-score classification by inclusion criteria: A fracture in spine Lumbar 1-4 and T-score ≤ -2.0] Not Applicable	164 Participants n=5 Participants	165 Participants n=7 Participants	329 Participants n=5 Participants
T-score classification by inclusion criteria: Femoral neck T-score ≤ -2.5 Femoral neck T-score ≤ -2.5	43 Participants n=5 Participants	58 Participants n=7 Participants	101 Participants n=5 Participants
T-score classification by inclusion criteria: Femoral neck T-score ≤ -2.5 Not Applicable	130 Participants n=5 Participants	112 Participants n=7 Participants	242 Participants n=5 Participants
T-score classification by inclusion criteria: Femoral total T-score ≤ -2.5 Femoral total T-score ≤ -2.5	20 Participants n=5 Participants	25 Participants n=7 Participants	45 Participants n=5 Participants
T-score classification by inclusion criteria: Femoral total T-score ≤ -2.5 Not Applicable	153 Participants n=5 Participants	145 Participants n=7 Participants	298 Participants n=5 Participants
T-score classification by inclusion criteria: Spine (average of spine Lumbar 1-4 ) T-score ≤-2.5 Spine (average of spine Lumbar 1-4 ) T-score ≤-2.5	144 Participants n=5 Participants	132 Participants n=7 Participants	276 Participants n=5 Participants
T-score classification by inclusion criteria: Spine (average of spine Lumbar 1-4 ) T-score ≤-2.5 Not Applicable	29 Participants n=5 Participants	38 Participants n=7 Participants	67 Participants n=5 Participants
Two or more fractures in spine (Lumbar 1-4) Two or more fractures in spine(Lumbar 1-4)	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Two or more fractures in spine (Lumbar 1-4) Not Applicable	170 Participants n=5 Participants	166 Participants n=7 Participants	336 Participants n=5 Participants
A fracture in spine Lumbar 1, Lumbar 2, Lumbar 3, Lumbar 4 and T-score ≤-2.0	-2.44 T-score STANDARD_DEVIATION 0.71 • n=5 Participants	-2.34 T-score STANDARD_DEVIATION 0.3 • n=7 Participants	-2.40 T-score STANDARD_DEVIATION 0.59 • n=5 Participants
Diastolic Blood Pressure	72.5 mm Hg STANDARD_DEVIATION 8.84 • n=5 Participants	73.82 mm Hg STANDARD_DEVIATION 8.85 • n=7 Participants	73.15 mm Hg STANDARD_DEVIATION 8.86 • n=5 Participants
Femoral neck T-score ≤ -2.5	-2.95 T-score STANDARD_DEVIATION 0.48 • n=5 Participants	-2.94 T-score STANDARD_DEVIATION 0.42 • n=7 Participants	-2.94 T-score STANDARD_DEVIATION 0.45 • n=5 Participants
Femoral total T-score ≤ -2.5	-3.00 T-score STANDARD_DEVIATION 0.52 • n=5 Participants	-3.00 T-score STANDARD_DEVIATION 0.41 • n=7 Participants	-3.00 T-score STANDARD_DEVIATION 0.46 • n=5 Participants
Height	152.11 Centimeters STANDARD_DEVIATION 5.88 • n=5 Participants	152.47 Centimeters STANDARD_DEVIATION 5.59 • n=7 Participants	152.29 Centimeters STANDARD_DEVIATION 5.73 • n=5 Participants
Serum PTH (Parathyroid hormone)	25.27 pg/ml STANDARD_DEVIATION 11.01 • n=5 Participants	23.47 pg/ml STANDARD_DEVIATION 11.85 • n=7 Participants	24.38 pg/ml STANDARD_DEVIATION 11.45 • n=5 Participants
Spine (average of spine Lumbar 1, Lumbar 2, Lumbar 3, Lumbar 4 ) T-score ≤ -2.5	-2.96 T-score STANDARD_DEVIATION 0.40 • n=5 Participants	-3.06 T-score STANDARD_DEVIATION 0.50 • n=7 Participants	-3.01 T-score STANDARD_DEVIATION 0.45 • n=5 Participants
Systolic Blood Pressure	122.83 mm Hg STANDARD_DEVIATION 15.8 • n=5 Participants	124.08 mm Hg STANDARD_DEVIATION 14.52 • n=7 Participants	123.45 mm Hg STANDARD_DEVIATION 15.17 • n=5 Participants
Weight	53.84 Kilograms STANDARD_DEVIATION 6.89 • n=5 Participants	54.8 Kilograms STANDARD_DEVIATION 7.03 • n=7 Participants	54.32 Kilograms STANDARD_DEVIATION 6.97 • n=5 Participants
serum 25 OHD (Serum 25-hydroxyvitamin D)	18.82 ng/ml STANDARD_DEVIATION 6.46 • n=5 Participants	18.71 ng/ml STANDARD_DEVIATION 6.25 • n=7 Participants	18.77 ng/ml STANDARD_DEVIATION 6.35 • n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.

Outcome measures

Outcome measures
Measure	Fosamax Plus D n=136 Participants Once weekly Fosamax plus D tablet \[Alendronate sodium 70 mg/Cholecalciferol 5600 IU\] + once daily calcium formulation \[500 mg/day\]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria	Fosamax n=132 Participants Once weekly Fosamax 70 mg tablet \[Alendronate sodium 70 mg\] + once daily calcium formulation \[500 mg/day\], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment With Vitamin D Deficiency	2 participants	55 participants
Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment Without Vitamin D Deficiency	134 participants	77 participants

SECONDARY outcome

Timeframe: Baseline and 16 weeks

Outcome measures

Outcome measures
Measure	Fosamax Plus D n=136 Participants Once weekly Fosamax plus D tablet \[Alendronate sodium 70 mg/Cholecalciferol 5600 IU\] + once daily calcium formulation \[500 mg/day\]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria	Fosamax n=132 Participants Once weekly Fosamax 70 mg tablet \[Alendronate sodium 70 mg\] + once daily calcium formulation \[500 mg/day\], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment	8.17 Percentage Change Serum PTH Interval -3.24 to 19.58	29.98 Percentage Change Serum PTH Interval 18.34 to 41.62

POST_HOC outcome

Timeframe: 16 weeks

Outcome measures

Outcome measures
Measure	Fosamax Plus D n=136 Participants Once weekly Fosamax plus D tablet \[Alendronate sodium 70 mg/Cholecalciferol 5600 IU\] + once daily calcium formulation \[500 mg/day\]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria	Fosamax n=132 Participants Once weekly Fosamax 70 mg tablet \[Alendronate sodium 70 mg\] + once daily calcium formulation \[500 mg/day\], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Less and Greater Than 20 ng/ml at 16 Weeks of Treatment With 25 OHD < 20ng/ml at 16 weeks of treatment	7 participants	93 participants
Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Less and Greater Than 20 ng/ml at 16 Weeks of Treatment With 25 OHD >= 20ng/ml at 16 weeks of treatment	129 participants	39 participants

POST_HOC outcome

Timeframe: 16 weeks

Outcome measures

Outcome measures
Measure	Fosamax Plus D n=136 Participants Once weekly Fosamax plus D tablet \[Alendronate sodium 70 mg/Cholecalciferol 5600 IU\] + once daily calcium formulation \[500 mg/day\]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria	Fosamax n=132 Participants Once weekly Fosamax 70 mg tablet \[Alendronate sodium 70 mg\] + once daily calcium formulation \[500 mg/day\], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
Mean Serum 25 OHD(Serum 25-hydroxyvitamin D) at 16 Weeks of Treatment	30.08 ng/ml Standard Deviation 5.87	17.14 ng/ml Standard Deviation 6.04

Adverse Events

Fosamax Plus D

Serious events: 7 serious events

Other events: 60 other events

Deaths: 0 deaths

Fosamax

Serious events: 1 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fosamax Plus D n=171 participants at risk Once weekly Fosamax plus D tablet \[Alendronate sodium 70 mg/Cholecalciferol 5600 IU\] + once daily calcium formulation \[500 mg/day\]), 16 weeks and patients who received drugs at least once after randomization and was analyzed according to the actually administered study drugs	Fosamax n=170 participants at risk Once weekly Fosamax 70 mg tablet \[Alendronate sodium 70 mg\] + once daily calcium formulation \[500 mg/day\]), 16 weeks and patients who received drugs at least once after randomization and was analyzed according to the actually administered study drugs
Infections and infestations Herpes zoster	0.58% 1/171 • Number of events 1 • Adverse events were followed up until 14 days after the last dose of investigational drug. 1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group. 1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.	0.00% 0/170 • Adverse events were followed up until 14 days after the last dose of investigational drug. 1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group. 1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.
Infections and infestations Lung abscess	0.58% 1/171 • Number of events 1 • Adverse events were followed up until 14 days after the last dose of investigational drug. 1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group. 1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.	0.00% 0/170 • Adverse events were followed up until 14 days after the last dose of investigational drug. 1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group. 1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.
Infections and infestations Otitis media	0.58% 1/171 • Number of events 1 • Adverse events were followed up until 14 days after the last dose of investigational drug. 1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group. 1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.	0.00% 0/170 • Adverse events were followed up until 14 days after the last dose of investigational drug. 1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group. 1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.
Infections and infestations Pneumonia	0.58% 1/171 • Number of events 1 • Adverse events were followed up until 14 days after the last dose of investigational drug. 1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group. 1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.	0.00% 0/170 • Adverse events were followed up until 14 days after the last dose of investigational drug. 1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group. 1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.
Musculoskeletal and connective tissue disorders Myalgia	0.58% 1/171 • Number of events 1 • Adverse events were followed up until 14 days after the last dose of investigational drug. 1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group. 1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.	0.00% 0/170 • Adverse events were followed up until 14 days after the last dose of investigational drug. 1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group. 1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.00% 0/171 • Adverse events were followed up until 14 days after the last dose of investigational drug. 1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group. 1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.	0.59% 1/170 • Number of events 1 • Adverse events were followed up until 14 days after the last dose of investigational drug. 1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group. 1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.
General disorders Pyrexia	0.58% 1/171 • Number of events 1 • Adverse events were followed up until 14 days after the last dose of investigational drug. 1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group. 1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.	0.00% 0/170 • Adverse events were followed up until 14 days after the last dose of investigational drug. 1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group. 1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.58% 1/171 • Number of events 1 • Adverse events were followed up until 14 days after the last dose of investigational drug. 1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group. 1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.	0.00% 0/170 • Adverse events were followed up until 14 days after the last dose of investigational drug. 1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group. 1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.
Nervous system disorders Cerebrovascular accident	0.58% 1/171 • Number of events 1 • Adverse events were followed up until 14 days after the last dose of investigational drug. 1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group. 1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.	0.00% 0/170 • Adverse events were followed up until 14 days after the last dose of investigational drug. 1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group. 1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.
Reproductive system and breast disorders Cystocele	0.58% 1/171 • Number of events 1 • Adverse events were followed up until 14 days after the last dose of investigational drug. 1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group. 1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.	0.00% 0/170 • Adverse events were followed up until 14 days after the last dose of investigational drug. 1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group. 1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.
Reproductive system and breast disorders Uterine prolapse	0.58% 1/171 • Number of events 1 • Adverse events were followed up until 14 days after the last dose of investigational drug. 1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group. 1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.	0.00% 0/170 • Adverse events were followed up until 14 days after the last dose of investigational drug. 1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group. 1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck 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