Trial Information

Summary: A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)

Status: Completed

Protocol Number: ML19334

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized double-blind study to determine the time to onset of suppression of the bone resorption marker sCTX with once-monthly Boniva (ibandronate) versus placebo in the treatment of post-menopausal osteoporosis

Brief Summary: This study will determine the rapidity of suppression of the bone resorption marker sCTX in post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated. Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with vitamin D and calcium supplementation. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 63.

Study Phase: IV

Study Design / Study Details:

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

Study Type:

Interventional

Condition: Post-Menopausal Osteoporosis

Intervention Type: Drug

Intervention Name: ibandondronate [Bonviva/Boniva]

Primary Outcome: 1. Percentage of patients whose sCTX concentration decreases by >=8%. Time frame: Day 3

Key Secondary Outcomes: 1. Percentage of patients whose sCTX concentration decreases by >=8% Time frame: Throughout study 2. Change in BSAP Time frame: Throughout study 3. Change in PTH Time frame: Month 1 Day 7, and Month 6 Day 7. 4. AEs and laboratory parameters Time frame: Throughout study

Inclusion Criteria:

  • women who have been newly diagnosed with post-menopausal osteoporosis, requiring treatment;
  • naive to bisphosphonate treatment,or had bisphosphonate treatment for a maximum of 3 months, at least 5 years before screening.

Exclusion Criteria:

  • patients on HRT within the last 3 months;
  • patients on other osteoporosis medication within the last 3 months;
  • sCTX below lower limit, or above 3 times the upper limit, of normal premenopausal level;
  • hypersensitivity to any component of ibandronate;
  • contraindication for calcium or vitamin D therapy;
  • history of major gastrointestinal upset;
  • malignant disease diagnosed within the previous 10 years (except resected basal cell cancer).

Gender: Females

Age Limits: Min: 65 Years

Accepts Healthy Volunteers: Yes

Trial Registration Date: 03/16/2006

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
La Jolla, CA 92037
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: September 2, 2008 at 2:12:54 PM


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