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A Study of Monthly Risedronate for Osteoporosis

Primary Purpose

Postmenopausal Osteoporosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
risedronate
risedronate
Sponsored by
Warner Chilcott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring randomized controlled trial, osteoporosis, risedronate

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

5 mg risedronate, once daily for 2 years

150 mg risedronate taken once a month for 2 years

Outcomes

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
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
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
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)
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
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
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
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
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
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
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
ng / mL = nanograms / milliliter. Assayed by electrochemiluminescent immunoassay.
Percent Change From Baseline in Serum CTX at Month 6, ITT Population
Assayed by electrochemiluminescent immunoassay.
Change From Baseline in Serum CTX at Month 24, ITT Population
Assayed by electrochemiluminescent immunoassay.
Percent Change From Baseline in Serum CTX at Month 24, ITT Population
Assayed by electrochemiluminescent immunoassay.
Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population
ug / L = micrograms per liter, Assayed by ELISA (enzyme-linked immunosorbent assay)
Percent Change From Baseline in Serum BAP at Month 6, ITT Population
Assayed by ELISA (enzyme-linked immunosorbent assay)
Change From Baseline in Serum BAP at Month 24, ITT Population
Assayed by ELISA (enzyme-linked immunosorbent assay)
Percent Change From Baseline in Serum BAP at Month 24, ITT Population
Assayed by ELISA (enzyme-linked immunosorbent assay)
Number of Participants With New Vertebral Fracture at Month 12, ITT Population
At least 1 new fractured vertebra
Number of Participants With New Vertebral Fracture at Month 24, ITT Population
At least 1 new fractured vertebra

Full Information

First Posted
October 28, 2005
Last Updated
April 15, 2013
Sponsor
Warner Chilcott
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00247273
Brief Title
A Study of Monthly Risedronate for Osteoporosis
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warner Chilcott
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
The comparator arms of this risedronate study are 150 mg monthly and 5 mg daily.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis
Keywords
randomized controlled trial, osteoporosis, risedronate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1294 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
5 mg risedronate, once daily for 2 years
Arm Title
2
Arm Type
Experimental
Arm Description
150 mg risedronate taken once a month for 2 years
Intervention Type
Drug
Intervention Name(s)
risedronate
Intervention Description
tablet, 5 mg risedronate, once a day for 2 years
Intervention Type
Drug
Intervention Name(s)
risedronate
Intervention Description
oral, 150 mg risedronate, once a month for 2 years
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population
Description
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).
Time Frame
Baseline to Month 12 - Endpoint
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population
Description
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
Time Frame
Baseline to Month 12
Title
Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population
Description
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
Time Frame
Baseline to Month 12
Title
Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24)
Description
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).
Time Frame
Baseline to Month 24 - Endpoint
Title
Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population
Description
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
Time Frame
Baseline to Month 24
Title
Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population
Description
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
Time Frame
Baseline to Month 24
Title
Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population
Description
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
Time Frame
Baseline to Month 6
Title
Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population
Description
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.
Time Frame
Baseline to Month 6
Title
Change From Baseline in Urine NTX/Cr at Month 24, ITT Population
Description
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.
Time Frame
Baseline to Month 24
Title
Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population
Description
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.
Time Frame
Baseline to Month 24
Title
Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population
Description
ng / mL = nanograms / milliliter. Assayed by electrochemiluminescent immunoassay.
Time Frame
Baseline to Month 6
Title
Percent Change From Baseline in Serum CTX at Month 6, ITT Population
Description
Assayed by electrochemiluminescent immunoassay.
Time Frame
Baseline to Month 6
Title
Change From Baseline in Serum CTX at Month 24, ITT Population
Description
Assayed by electrochemiluminescent immunoassay.
Time Frame
Baseline to Month 24
Title
Percent Change From Baseline in Serum CTX at Month 24, ITT Population
Description
Assayed by electrochemiluminescent immunoassay.
Time Frame
Baseline to Month 24
Title
Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population
Description
ug / L = micrograms per liter, Assayed by ELISA (enzyme-linked immunosorbent assay)
Time Frame
Baseline to Month 6
Title
Percent Change From Baseline in Serum BAP at Month 6, ITT Population
Description
Assayed by ELISA (enzyme-linked immunosorbent assay)
Time Frame
Baseline to Month 6
Title
Change From Baseline in Serum BAP at Month 24, ITT Population
Description
Assayed by ELISA (enzyme-linked immunosorbent assay)
Time Frame
Baseline to Month 24
Title
Percent Change From Baseline in Serum BAP at Month 24, ITT Population
Description
Assayed by ELISA (enzyme-linked immunosorbent assay)
Time Frame
Baseline to Month 24
Title
Number of Participants With New Vertebral Fracture at Month 12, ITT Population
Description
At least 1 new fractured vertebra
Time Frame
Baseline to Month 12
Title
Number of Participants With New Vertebral Fracture at Month 24, ITT Population
Description
At least 1 new fractured vertebra
Time Frame
Baseline to Month 24

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sal Bartelmo, MD
Organizational Affiliation
P&G
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80227
Country
United States
Facility Name
Research Site
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Research Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
068131
Country
United States
Facility Name
Research Site
City
West Haverstraw
State/Province
New York
ZIP/Postal Code
10983
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97212
Country
United States
Facility Name
Research Site
City
Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Capital Federal
Country
Argentina
Facility Name
Research Site
City
Geelong
Country
Australia
Facility Name
Research Site
City
Heidelberg, Victoria
Country
Australia
Facility Name
Research Site
City
Saint Leonards
Country
Australia
Facility Name
Research Site
City
Brussels
Country
Belgium
Facility Name
Research Site
City
Gent
Country
Belgium
Facility Name
Research Site
City
Leuven
Country
Belgium
Facility Name
Research Site
City
Liege
Country
Belgium
Facility Name
Research Site
City
Mont Godinne
Country
Belgium
Facility Name
Research Site
City
Rio de Janeiro
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
Country
Brazil
Facility Name
Research Site
City
Calgary
Country
Canada
Facility Name
Research Site
City
Montreal
Country
Canada
Facility Name
Research Site
City
Sainte Foy
Country
Canada
Facility Name
Research Site
City
Saskatoon
Country
Canada
Facility Name
Research Site
City
Parnu
Country
Estonia
Facility Name
Research Site
City
Tartu
Country
Estonia
Facility Name
Research Site
City
Helsinki
Country
Finland
Facility Name
Research Site
City
Kuopio
Country
Finland
Facility Name
Research Site
City
Oulu
Country
Finland
Facility Name
Research Site
City
Turku
Country
Finland
Facility Name
Research Site
City
Amiens Cedex 1
Country
France
Facility Name
Research Site
City
Lyon Cedex
Country
France
Facility Name
Research Site
City
Orleans
Country
France
Facility Name
Research Site
City
Paris
Country
France
Facility Name
Research Site
City
Toulouse
Country
France
Facility Name
Research Site
City
Vandoeuvre Les Nancy
Country
France
Facility Name
Research Site
City
Balatonfured
Country
Hungary
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Gyor
Country
Hungary
Facility Name
Research Site
City
Miskolc
Country
Hungary
Facility Name
Research Site
City
Nagykanizs
Country
Hungary
Facility Name
Research Site
City
Beirut
Country
Lebanon
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Paradis
Country
Norway
Facility Name
Research Site
City
Trondheim
Country
Norway
Facility Name
Research Site
City
Bialystok
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Granada
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain

12. IPD Sharing Statement

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A Study of Monthly Risedronate for Osteoporosis

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