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A Study of Monthly Risedronate for Osteoporosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00247273
First Posted: November 1, 2005
Last Update Posted: April 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Warner Chilcott
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Postmenopausal Osteoporosis (PMO)

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population [ Time Frame: Baseline to Month 12 - Endpoint ]
    BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 12).


Secondary Outcome Measures:
  • Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population [ Time Frame: Baseline to Month 12 ]
    BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.

  • Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population [ Time Frame: Baseline to Month 12 ]
    BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.

  • Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24) [ Time Frame: Baseline to Month 24 - Endpoint ]
    BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 24).

  • Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population [ Time Frame: Baseline to Month 24 ]
    BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.

  • Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population [ Time Frame: Baseline to Month 24 ]
    BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.

  • Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population [ Time Frame: Baseline to Month 6 ]
    Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24. nmol BCE / mmol Creatinine = nanomoles bone collagen equivalents / millimoles Creatinine

  • Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population [ Time Frame: Baseline to Month 6 ]
    Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.

  • Change From Baseline in Urine NTX/Cr at Month 24, ITT Population [ Time Frame: Baseline to Month 24 ]
    Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.

  • Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population [ Time Frame: Baseline to Month 24 ]
    Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.

  • Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population [ Time Frame: Baseline to Month 6 ]
    ng / mL = nanograms / milliliter. Assayed by electrochemiluminescent immunoassay.

  • Percent Change From Baseline in Serum CTX at Month 6, ITT Population [ Time Frame: Baseline to Month 6 ]
    Assayed by electrochemiluminescent immunoassay.

  • Change From Baseline in Serum CTX at Month 24, ITT Population [ Time Frame: Baseline to Month 24 ]
    Assayed by electrochemiluminescent immunoassay.

  • Percent Change From Baseline in Serum CTX at Month 24, ITT Population [ Time Frame: Baseline to Month 24 ]
    Assayed by electrochemiluminescent immunoassay.

  • Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population [ Time Frame: Baseline to Month 6 ]
    ug / L = micrograms per liter, Assayed by ELISA (enzyme-linked immunosorbent assay)

  • Percent Change From Baseline in Serum BAP at Month 6, ITT Population [ Time Frame: Baseline to Month 6 ]
    Assayed by ELISA (enzyme-linked immunosorbent assay)

  • Change From Baseline in Serum BAP at Month 24, ITT Population [ Time Frame: Baseline to Month 24 ]
    Assayed by ELISA (enzyme-linked immunosorbent assay)

  • Percent Change From Baseline in Serum BAP at Month 24, ITT Population [ Time Frame: Baseline to Month 24 ]
    Assayed by ELISA (enzyme-linked immunosorbent assay)

  • Number of Participants With New Vertebral Fracture at Month 12, ITT Population [ Time Frame: Baseline to Month 12 ]
    At least 1 new fractured vertebra

  • Number of Participants With New Vertebral Fracture at Month 24, ITT Population [ Time Frame: Baseline to Month 24 ]
    At least 1 new fractured vertebra


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
Active Comparator: 1
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
Experimental: 2
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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 (bone mineral density) more that 2.5 standard deviations (SD) below the young adult mean, or have 1-spine BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture

Exclusion Criteria:

  • history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
  • BMI (body mass index) >32 kg/m^2
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00247273


  Show 49 Study Locations
Sponsors and Collaborators
Warner Chilcott
Sanofi
Investigators
Study Director: Sal Bartelmo, MD P&G
  More Information

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00247273     History of Changes
Other Study ID Numbers: 2005032
EFC6062 AND HMRF004M/3001
First Submitted: October 28, 2005
First Posted: November 1, 2005
Results First Submitted: March 4, 2011
Results First Posted: June 21, 2011
Last Update Posted: April 22, 2013
Last Verified: April 2013

Keywords provided by Warner Chilcott:
randomized controlled trial, osteoporosis, risedronate

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Risedronate Sodium
Etidronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents
Physiological Effects of Drugs