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Completed

NCT Number: NCT00551174

A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment

This 2-arm study was designed to assess the long-term safety and tolerability of intravenous (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received daily supplementation with vitamin D and calcium. The anticipated time on study treatment was 2+ years, and the target sample size was 500+ individuals.

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Key information

Conditions

Post-Menopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

St Leonards, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Successful completion of Bonviva study BM16550 (NCT00048074), with at least 75% compliance
  • Ambulatory

Exclusion criteria

  • Patients who completed the Bonviva study BM16550 (NCT00048074) >3 months before the planned start date for this study
  • Malignant disease diagnosed since inclusion into previous study
  • Treatment with drugs affecting bone metabolism since inclusion into previous study

Treatment and study plan

ibandronate [Bonviva/Boniva]

Drug

3 mg IV every 3 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).

Primary outcomes

  1. Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months

    Time frame: Baseline,12, 24 and 36 months

    Relative change percent(%) from baseline of MA17904 and BM16550 (NCT00048074) in mean lumbar spine (L2-L4) BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17940.Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.

Secondary outcomes

  1. Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months

    Time frame: Baseline,12, 24 and 36 months

    Relative change percent (%) from baseline of MA17904 and BM16550 (NCT00048074) in mean total hip BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.

  2. Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months

    Time frame: Baseline, 6, 12, 24 and 36 months (i.e., 2.5, 3, 4 and 5 years after initiation of BM16550)

    Relative percent (%) change from baseline of MA17904 and BM16550 (NCT00048074) in serum C-telopeptide crosslinks of type I collagen (CTX) at trough at 6, 12, 24 and 36 months- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=6, 12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.

  3. Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months

    Time frame: Baseline, 6 months

    Relative percent (%) change from MA17904 baseline of post-dose suppression of serum C-telopeptide crosslinks of type I collagen (CTX) at 6 months- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t= 6 months. The baseline value is used as a reference to calculate the relative change from baseline.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Open Label, Parallel Group, Multicenter Study of Two Intravenous (IV) Ibandronate Dose Regimens (2 mg Every 2 Months and 3 mg Every 3 Months) in Women With Postmenopausal Osteoporosis Who Completed Trial BM16550

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Oct 30, 2007
Registry last updated
Jul 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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