Trial Outcomes & Findings for A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis (NCT NCT02598934)
NCT ID: NCT02598934
Last Updated: 2016-03-09
Results Overview
Serum CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
308 participants
Primary outcome timeframe
Baseline, Month 6
Results posted on
2016-03-09
Participant Flow
Participant milestones
| Measure |
Ibandronate (Consult Group)
Participants received ibandronate 150-milligram (mg) tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and received physician consultation on bone turnover marker (BTM) response.
|
Ibandronate (Non-consult Group)
Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
|
|---|---|---|
|
Overall Study
STARTED
|
154
|
154
|
|
Overall Study
COMPLETED
|
135
|
132
|
|
Overall Study
NOT COMPLETED
|
19
|
22
|
Reasons for withdrawal
| Measure |
Ibandronate (Consult Group)
Participants received ibandronate 150-milligram (mg) tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and received physician consultation on bone turnover marker (BTM) response.
|
Ibandronate (Non-consult Group)
Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
13
|
|
Overall Study
Failure to Return
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Administrative
|
2
|
1
|
|
Overall Study
Protocol Violation
|
1
|
2
|
Baseline Characteristics
A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis
Baseline characteristics by cohort
| Measure |
Ibandronate (Consult Group)
n=154 Participants
Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and received physician consultation on BTM response.
|
Ibandronate (Non-consult Group)
n=154 Participants
Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
|
Total
n=308 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 9.94 • n=5 Participants
|
64.9 years
STANDARD_DEVIATION 9.69 • n=7 Participants
|
65.1 years
STANDARD_DEVIATION 9.80 • n=5 Participants
|
|
Sex: Female, Male
Female
|
154 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
308 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: ITT population observed cases: all participants of ITT population with available data for this outcome measure.
Serum CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
Outcome measures
| Measure |
Ibandronate (All Participants)
n=260 Participants
Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.
Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group.
|
Ibandronate (Non-consult Group)
Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
|
|---|---|---|
|
Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX)
|
-55.26 percent change
Standard Deviation 57.255
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: ITT population observed cases: all participants of ITT population with available data for this outcome measure.
Urine NTX is a measure of bone resorption and is measured as millimoles bone collagen equivalents per millimoles creatinine. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
Outcome measures
| Measure |
Ibandronate (All Participants)
n=204 Participants
Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.
Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group.
|
Ibandronate (Non-consult Group)
Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
|
|---|---|---|
|
Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX)
|
-45.98 percent change
Standard Deviation 28.421
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: ITT population observed cases: all participants of ITT population with available data for this outcome measure.
Serum P1NP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus Baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
Outcome measures
| Measure |
Ibandronate (All Participants)
n=235 Participants
Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.
Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group.
|
Ibandronate (Non-consult Group)
Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
|
|---|---|---|
|
Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)
|
-58.14 percent change
Standard Deviation 25.334
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: ITT population observed cases: all participants of ITT population with available data for this outcome measure.
Serum osteocalcin is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
Outcome measures
| Measure |
Ibandronate (All Participants)
n=248 Participants
Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.
Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group.
|
Ibandronate (Non-consult Group)
Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
|
|---|---|---|
|
Percent Change From Baseline to Month 6 in Serum Osteocalcin
|
-41.51 percent change
Standard Deviation 19.448
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: ITT population observed cases: all participants of ITT population with available data for this outcome measure.
Serum BSAP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
Outcome measures
| Measure |
Ibandronate (All Participants)
n=253 Participants
Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.
Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group.
|
Ibandronate (Non-consult Group)
Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
|
|---|---|---|
|
Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP)
|
-35.34 percent change
Standard Deviation 17.386
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: ITT population
The BCS is designed to measure the participant's confidence level that Boniva (ibandronate) therapy is effective in treating osteoporosis and reducing the risk of fracture. Response options ranged on a 5-point scale from 'Not At All Confident' to 'Very Confident.' A Boniva confidence responder was defined as a participant who reported a response of 'confident' or 'very confident' on the 2 items in BCS. (1) ibandronate was effective in treating osteoporosis and (2) ibandronate reduces the risk of breaking a bone.
Outcome measures
| Measure |
Ibandronate (All Participants)
n=154 Participants
Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.
Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group.
|
Ibandronate (Non-consult Group)
n=154 Participants
Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
|
|---|---|---|
|
Percentage of Participants Who Were "Very Confident" or "Confident" to Items on the Boniva Confidence Scale (BCS) at Month 6
(1) Effective in treating osteoporosis
|
68.8 percentage of participants
|
51.9 percentage of participants
|
|
Percentage of Participants Who Were "Very Confident" or "Confident" to Items on the Boniva Confidence Scale (BCS) at Month 6
(2) Reduces risk of breaking bone
|
64.9 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Were "Very Confident" or "Confident" to Items on the Boniva Confidence Scale (BCS) at Month 6
(1) or (2)
|
72.1 percentage of participants
|
55.2 percentage of participants
|
|
Percentage of Participants Who Were "Very Confident" or "Confident" to Items on the Boniva Confidence Scale (BCS) at Month 6
(1) and (2)
|
61.7 percentage of participants
|
46.8 percentage of participants
|
Adverse Events
Ibandronate (All Participants)
Serious events: 17 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ibandronate (All Participants)
n=308 participants at risk
Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months. Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group.
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
0.32%
1/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Cardiac disorders
Bradycardia
|
0.32%
1/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Cardiac disorders
Coronary artery disease
|
0.32%
1/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.65%
2/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.32%
1/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.32%
1/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Gastrointestinal disorders
Melena
|
0.32%
1/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.32%
1/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Infections and infestations
Pneumonia
|
0.32%
1/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.32%
1/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.32%
1/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.32%
1/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.32%
1/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.32%
1/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.32%
1/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.32%
1/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.32%
1/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.32%
1/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.32%
1/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.32%
1/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Nervous system disorders
Syncope
|
0.32%
1/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Renal and urinary disorders
Renal failure
|
0.32%
1/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
Other adverse events
| Measure |
Ibandronate (All Participants)
n=308 participants at risk
Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months. Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
8.4%
26/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Infections and infestations
Upper respiratory tract infection
|
5.5%
17/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
22/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.5%
17/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.2%
16/308 • AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but only after the first publication or presentation that involves the Overall Study. The sponsor may request that the confidential information be deleted and/or the publication to be postponed inorder to present the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER