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

Post Menopausal Osteoporosis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00303485
• Other study ID #: ML19334
• Status: Completed
• Phase: Phase 4
• First received: March 16, 2006
• Last updated: October 1, 2015
• Start date: February 2006
• Est. completion date: July 2007

Study information

• Verified date: October 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Post Menopausal Osteoporosis

Intervention

Drug:
• Placebo
po monthly for 6 months
• Vitamin D and calcium supplementation
As prescribed
• ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients whose sCTX concentration decreases by >=8%.		Day 3	No
Secondary	Percentage of patients whose sCTX concentration decreases by >=8%		Throughout study	No
Secondary	Change in BSAP		Throughout study	No
Secondary	Change in PTH		Month 1 Day 7, and Month 6 Day 7.	No
Secondary	AEs and laboratory parameters		Throughout study	No