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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00303485

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: ibandondronate [Bonviva/Boniva] Drug: Placebo Drug: Vitamin D and calcium supplementation	Phase IV

MedlinePlus related topics: Calcium Menopause Osteoporosis

Drug Information available for: Calcium gluconate Vitamin D Ergocalciferol Ibandronate sodium Ibandronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

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 Completion Date:	July 2007

Arms	Assigned Interventions
1: Experimental	Drug: ibandondronate [Bonviva/Boniva] 150mg po monthly for 6 months Drug: Vitamin D and calcium supplementation As prescribed
2: Placebo Comparator	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

La Jolla, California, United States, 92037

BEVERLY HILLS, California, United States, 90211
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

SAN JUAN, Puerto Rico, 00935

PONCE, Puerto Rico, 00717-1318

SANTURCE, Puerto Rico, 00909

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML19334
Study First Received:	March 16, 2006
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00303485
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Calcium, Dietary
Vitamin D
Ibandronic acid
Musculoskeletal Diseases
Bone Resorption
Ergocalciferols

Osteoporosis, Postmenopausal
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Menopause

Additional relevant MeSH terms:

Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009