Trial Outcomes & Findings for A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis (NCT NCT01290094)

NCT ID: NCT01290094

Last Updated: 2015-08-13

Results Overview

Percent change was calculated as \[(measure at time "t" minus \[-\] measure at baseline) divided by (/) measure at baseline\] multiplied by (\*) 100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 41 participants
• Primary outcome timeframe: Baseline, Month 12
• Results posted on: 2015-08-13

Participant Flow

Participant milestones

Measure	Ibandronate Participants received 3 milligrams (mg) ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
Overall Study STARTED	41
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Ibandronate Participants received 3 milligrams (mg) ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	5

Baseline Characteristics

A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis

Baseline characteristics by cohort

Measure	Ibandronate n=40 Participants Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
Age, Continuous	60.60 years STANDARD_DEVIATION 5.812 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: ITT population.

Percent change was calculated as [(measure at time "t" minus [-] measure at baseline) divided by (/) measure at baseline] multiplied by (*) 100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline.

Outcome measures

Measure	Ibandronate n=40 Participants Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12	5.67 percent change Standard Deviation 7.86

PRIMARY outcome

Timeframe: Baseline, Month 24

Population: ITT population. Here "number of participants analyzed" included participants who were evaluable for this outcome measure.

Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline.

Outcome measures

Measure	Ibandronate n=35 Participants Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24	5.27 percent change Standard Deviation 8.00

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: ITT population.

Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline.

Outcome measures

Measure	Ibandronate n=40 Participants Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
Percent Change From Baseline in Mean Hip Bone BMD at Month 12	2.68 percent change Standard Deviation 4.66

PRIMARY outcome

Timeframe: Baseline, Month 24

Population: ITT population. Here "number of participants analyzed" included participants who were evaluable for this outcome measure.

Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline.

Outcome measures

Measure	Ibandronate n=35 Participants Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
Percent Change From Baseline in Mean Hip BMD at Month 24	1.71 percent change Standard Deviation 5.09

SECONDARY outcome

Timeframe: Baseline, Month 12, Month 24

Population: ITT population. Here "n" included participants who were evaluable at specified time point for the given arm.

Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis.

Outcome measures

Measure	Ibandronate n=40 Participants Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24 Change at Month 12 (n=40)	13.47 percent change Standard Deviation 12.23
Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24 Change at Month 24 (n=35)	12.48 percent change Standard Deviation 13.43

SECONDARY outcome

Timeframe: Baseline, Month 12, Month 24

Population: ITT population. Here "n" included participants who were evaluable at specified time point for the given arm.

Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis.

Outcome measures

Measure	Ibandronate n=40 Participants Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
Percent Change From Baseline in Total Hip T-score at Month 12 and 24 Change at Month 12 (n=40)	9.31 percent change Standard Deviation 16.75
Percent Change From Baseline in Total Hip T-score at Month 12 and 24 Change at Month 24 (n=35)	5.98 percent change Standard Deviation 17.90

SECONDARY outcome

Timeframe: Baseline up to Month 12

Population: ITT population.

Outcome measures

Measure	Ibandronate n=40 Participants Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
Percentage of Participants Who Received All Planned Study Medication (Compliance)	100 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Month 12

Population: ITT population.

Participant's profile included age, year since menopause, fracture history, and BMD at baseline.

Outcome measures

Measure	Ibandronate n=40 Participants Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
Correlation Coefficient of Participant's Profile With Compliance	NA correlation coefficient Since there was 100% compliance, it was decided not to perform the analysis of correlation coefficient of participant's Profile With Compliance.

Adverse Events

Ibandronate

Serious events: 9 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ibandronate n=40 participants at risk Participants received 3 mg ibandronate via intravenous injection, every 3 months for 9 months (total of 4 injections).
Injury, poisoning and procedural complications Fractures	7.5% 3/40 • Baseline up to follow-up (Month 24) ITT population.
Eye disorders Eyelid disorder	2.5% 1/40 • Baseline up to follow-up (Month 24) ITT population.
Injury, poisoning and procedural complications Contusion	2.5% 1/40 • Baseline up to follow-up (Month 24) ITT population.
Nervous system disorders Diabetic neuropathy	2.5% 1/40 • Baseline up to follow-up (Month 24) ITT population.
Ear and labyrinth disorders Vertigo	2.5% 1/40 • Baseline up to follow-up (Month 24) ITT population.
Nervous system disorders Loss of conciousness	2.5% 1/40 • Baseline up to follow-up (Month 24) ITT population.
Endocrine disorders Hypothyroidism	2.5% 1/40 • Baseline up to follow-up (Month 24) ITT population.
Hepatobiliary disorders Gallbladder disorder	2.5% 1/40 • Baseline up to follow-up (Month 24) ITT population.

Other adverse events

Measure	Ibandronate n=40 participants at risk Participants received 3 mg ibandronate via intravenous injection, every 3 months for 9 months (total of 4 injections).
Gastrointestinal disorders Gastrointestinal pain	5.0% 2/40 • Baseline up to follow-up (Month 24) ITT population.
General disorders Flu like symptoms	30.0% 12/40 • Baseline up to follow-up (Month 24) ITT population.
General disorders Injection site reaction	5.0% 2/40 • Baseline up to follow-up (Month 24) ITT population.
Nervous system disorders Neuralgia	10.0% 4/40 • Baseline up to follow-up (Month 24) ITT population.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: genentech@druginfo.com

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 Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER