A Study of Monthly Risedronate for Osteoporosis - Full Text View

Sponsors and Collaborators:	Procter and Gamble Sanofi-Aventis
Information provided by:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00247273

Purpose

The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

Condition	Intervention	Phase
Postmenopausal Osteoporosis	Drug: risedronate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly With 5 mg Risedronate Daily in the Treatment of PMO

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 Procter and Gamble:

Primary Outcome Measures:

Percent change from baseline in lumbar spine BMD in 12 months in women with post menopausal osteoporosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in BMD of the total proximal femur, femoral neck, and trochanter at months 6, 12, 24 [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
Number of patients with at least one new vertebral body fracture at months 12 and 24 [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Bone turnover marker changes at months 3, 6, 24 [ Time Frame: 3, 6, and 24 Months ] [ Designated as safety issue: No ]
Safety parameters including clinical laboratory values, vital signs and adverse event profiles [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]

Enrollment:	1294
Study Start Date:	October 2005
Study Completion Date:	April 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 5 mg risedronate, once daily for 2 years	Drug: risedronate tablet, 5 mg risedronate, once a day for 2 years Drug: risedronate oral, 150 mg risedronate, once a month for 2 years
2: Experimental 150 mg risedronate taken once a month for 2 years	Drug: risedronate oral, 150 mg risedronate, once a month for 2 years

Detailed Description:

The comparator arms of this risedronate study are 150 mg monthly and 5 mg daily.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female: 50 years of age or older
>5 years since last menses natural or surgical
have lumbar spine BMD more that 2.5 SD below the yond adult mean, or have 1-spine BMD more than 2.0 SD below the yond adult female mean value and also have at least one prevalent vertebral body fracture

Exclusion Criteria:

history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
BMI >32 kg/m
use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
hypocalcemia or hypercalcemia of any cause
markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247273

Show 49 Study Locations

Sponsors and Collaborators

Procter and Gamble

Sanofi-Aventis

Investigators

Study Director:

Sal Bartelmo, MD

P&G

More Information

No publications provided

Responsible Party:	Procter and Gamble Pharmaceuticals ( Sal Bartelmo, MD )
Study ID Numbers:	2005032, EFC6062 AND HMRF004M/3001
Study First Received:	October 28, 2005
Last Updated:	July 17, 2009
ClinicalTrials.gov Identifier:	NCT00247273 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Procter and Gamble:

randomized controlled trial, osteoporosis, risedronate

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 10, 2009