Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women - Full Text View

Sponsors and Collaborators:	Sanofi-Aventis Procter and Gamble
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00353080

Purpose

To confirm the superiority of 5 mg daily risedronate as compared to placebo in maintaining or increasing bone mass in lumbar spine in osteopenic postmenopausal women

To confirm the efficacy of 5 mg daily risedronate in osteopenic postmenopausal women in maintaining or increasing bone mass in proximal femur and decreasing bone resorption

To confirm general safety of 5 mg daily risedronate as compared to placebo

Condition	Intervention	Phase
Osteoporosis, Postmenopausal	Drug: risedronate (HMR4003)	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Two-Year, Multicenter, Double-Blind, Randomized, Placebo-Controlled and Parallel Group Study of Oral Risedronate 5 mg Daily in the Prevention of Osteoporosis in Osteopenic Postmenopausal Women (More Than 5 Years Postmenopausal)

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Risedronic acid Risedronate sodium

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Percent changes from baseline in lumbar spine bone mineral density (BMD) at Month 24 measured by DXA.

Secondary Outcome Measures:

Percent changes in proximal femur BMD from baseline at month 12 and 24 (DXA)
Percent of responders (subjects with a positive change in lumbar spine BMD from baseline)at Month 12 and 24
Percent changes in bone turnover markers after 12 and 24 months of treatment
Physical examination and hematology tests before and after 12 and 24 months of treatment;Serum Chemistry before and after 6, 12 and 24 months of treatment
Occurrence of adverse events at each visit with special interest for upper gastro-intestinal events

Estimated Enrollment:	171
Study Start Date:	December 2002
Primary Completion Date:	April 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ambulatory, healthy postmenopausal women with
- Natural menopause and more than 5 years after their last menstrual period
- or surgical menopause and more than 5 years after surgery
- osteopenia (lumbar spine T score between 1 and 2.5 SD below the mean value in normal young women).
With at least one risk factor for osteoporosis

Exclusion Criteria:

Women who have received hormone replacement therapy (with estrogen and/or progestogen and/or androgen) or raloxifene within 3 months before visit 2 or calcitonin or calcitriol within 4 weeks before visit 2

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353080

Locations

Finland
Sanofi-aventis
Helsinki, Finland
Netherlands
Sanofi-aventis
Gouda, Netherlands
Norway
Sanofi-aventis
Oslo, Norway
Spain
Sanofi-aventis
Madrid, Spain
Sweden
Sanofi-aventis
Stockholm, Sweden

Sponsors and Collaborators

Sanofi-Aventis

Procter and Gamble

Investigators

Principal Investigator:

Välimäki Matti, MD

Division of Endocrinology, Helsinki University Central Hospital, Helsinki, Finland

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Välimäki MJ, Farrerons-Minguella J, Halse J, Kröger H, Maroni M, Mulder H, Muñoz-Torres M, Sääf M, Snorre Øfjord E. Effects of risedronate 5 mg/d on bone mineral density and bone turnover markers in late-postmenopausal women with osteopenia: a multinational, 24-month, randomized, double-blind, placebo-controlled, parallel-group, phase III trial. Clin Ther. 2007 Sep;29(9):1937-49.

Study ID Numbers:	EFC6064, HMR4003B/3001
Study First Received:	July 13, 2006
Last Updated:	March 27, 2009
ClinicalTrials.gov Identifier:	NCT00353080 History of Changes
Health Authority:	Finland: National Agency for Medicines; Netherlands: Medicines Evaluation Board (MEB); Norway: Norwegian Medicines Agency

Keywords provided by Sanofi-Aventis:

Prevention of postmenopausal osteoporosis

Study placed in the following topic categories:

Calcium, Dietary
Musculoskeletal Diseases
Osteoporosis, Postmenopausal
Calcium Channel Blockers
Osteoporosis

Bone Density Conservation Agents
Bone Diseases, Metabolic
Cardiovascular Agents
Bone Diseases
Risedronic acid

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Osteoporosis
Calcium Channel Blockers
Bone Diseases, Metabolic
Bone Density Conservation Agents
Cardiovascular Agents

Bone Diseases
Pharmacologic Actions
Membrane Transport Modulators
Musculoskeletal Diseases
Therapeutic Uses
Osteoporosis, Postmenopausal
Risedronic acid

ClinicalTrials.gov processed this record on September 03, 2009