Trial Information

Summary: MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis

Status: Completed

Protocol Number: BM16549

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study comparing the effect of monthly versus daily treatment with oral Bonviva on lumbar bone mineral density in women with osteoporosis

Brief Summary: This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals. Target sample size is 1592.

Study Phase: III

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double Blind
  • Control: Active
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Post-Menopausal Osteoporosis

Intervention Type: Drug

Intervention Name: ibandronate [Bonviva/Boniva]

Primary Outcome: 1. Relative change (%) from baseline in mean lumbar spine bone mineral density (BMD) Time frame: 12 months

Key Secondary Outcomes: 1. Relative change in mean lumbar spine BMD Time frame: 24 months 2. Relative and absolute change in total hip, trochanter, femoral neck BMD Time frame: 12 and 24 months 3. Percentage of responders Time frame: 12 and 24 months 4. Change from baseline in fasting serum CTX Time frame: 3, 6, 12 and 24 months 5. AEs, laboratory parameters Time frame: Throughout study

Inclusion Criteria:

  • women 55-80 years of age;
  • post-menopausal for >= 5 years;
  • ambulatory.

Exclusion Criteria:

  • malignant disease diagnosed within the previous 10 years (except basal cell cancer that has been successfully removed);
  • breast cancer within the previous 20 years;
  • allergy to bisphosphonates;
  • previous treatment with an intravenous bisphosphonate at any time;
  • previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within the last year, or >3 months of treatment within the last 2 years.

Gender: Females

Age Limits: Min: 55 Years Max: 80 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 06/24/2005

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Parkville, Australia, 3052
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: September 2, 2008 at 1:54:36 PM


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