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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00303485
First received: March 16, 2006
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Post-Menopausal Osteoporosis
 Drug: ibandronate [Bonviva/Boniva]
Drug: Placebo
Drug: Vitamin D and calcium supplementation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients whose sCTX concentration decreases by >=8%. [ Time Frame: Day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients whose sCTX concentration decreases by >=8% [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Change in BSAP [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Change in PTH [ Time Frame: Month 1 Day 7, and Month 6 Day 7. ] [ Designated as safety issue: No ]
  • AEs and laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: February 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months
Drug: Vitamin D and calcium supplementation
As prescribed
Placebo Comparator: 2 Drug: Placebo
po monthly for 6 months
Drug: Vitamin D and calcium supplementation
As prescribed

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00303485

Locations
United States, California
Beverly Hills, California, United States, 90211
La Jolla, California, United States, 92093
United States, Georgia
Augusta, Georgia, United States, 30904
United States, Minnesota
Woodbury, Minnesota, United States, 55125
United States, New York
Bronx, New York, United States, 10461
United States, Pennsylvania
Hopwood, Pennsylvania, United States, 15445
United States, Wisconsin
Madison, Wisconsin, United States, 53705
Puerto Rico
Ponce, Puerto Rico, 00717-1318
San Juan, Puerto Rico, 00935
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00303485     History of Changes
Other Study ID Numbers: ML19334
Study First Received: March 16, 2006
Last Updated: May 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Ibandronic acid
Vitamin D
 Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013