NCT00577395

Brief Summary

The purpose of this trial is to compare the difference in bone microarchitecture of the distal radius at month 12 in postmenopausal osteopenic women treated with risedronate 150mg taken once a month compared to placebo.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_4

Geographic Reach
2 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 20, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
11 months until next milestone

Results Posted

Study results publicly available

December 22, 2009

Completed
Last Updated

April 22, 2013

Status Verified

April 1, 2013

Enrollment Period

7 months

First QC Date

December 19, 2007

Results QC Date

November 18, 2009

Last Update Submit

April 15, 2013

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Percent Change From Baseline in Erosion Index (A Ratio of Curve-like Structures to Plate-like Structures and is a Measure of the Degree of Structural Degradation) of the Distal Radius

    The percent was change from baseline in erosion index at the distal radius between the risedronate and placebo groups at Month 12 (the lower the percent change in erosion index, the greater the improvement of structural degradation); the last valid postbaseline measurement was to be used when the Month 12 value was missing (Last Observation Carried Forward or LOCF). NOTE: The study was unable to recruit sufficient numbers of patients to meet with the protocol specified numbers, thus it was terminated early after 5 months. No efficacy analyses were performed.

    12 months

Secondary Outcomes (1)

  • Erosion Index of the Distal Radius

    6 months

Study Arms (2)

2

EXPERIMENTAL

one 150 mg risedronate once a month, orally

Drug: risedronate

1

PLACEBO COMPARATOR

Placebo tablet once a month, orally

Drug: placebo

Interventions

placeboDRUG

oral tablet once a month for 12 months

1
risedronateDRUG

tablet, 150 mg once a month for 12 months

2

Eligibility Criteria

Age40 Years - 57 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female: 40 and 57 years of age inclusive
  • cessation of menstruation (surgical or natural) between 12 and 36 months prior to study enrollment
  • have osteopenia defines as having the following: have osteopenia defined as having the following:
  • Lumbar spine (L1-L4) Bone Mineral Density (BMD) T score -1 and less than -2.5 AND a total hip T score of greater than -2.5 OR
  • Lumbar spine (L1-L4) BMD T score greater than -2.5 AND a total hip T score -1 and less than -2.5;
  • have a body mass index (BMI) between 18 and 30 kg/m2.

You may not qualify if:

  • history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Facility

Tuscon, Arizona, 85704, United States

Location

Research Facility

Omaha, Nebraska, 68729, United States

Location

Research Site

Cincinnati, Ohio, 45201, United States

Location

Research Facility

Buenos Aires, Argentina

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

NOTE: The study was terminated early (after 5 months), prior to acquiring any efficacy endpoints; consequently, NO subject efficacy analyses were performed

Results Point of Contact

Title
Grexan Wulff, Manager Regulatory Affairs
Organization
Warner Chilcott
gwulff@wcrx.com
973-442-3376

Study Officials

  • Ana M Balske, MD, PhD

    Procter and Gamble

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 20, 2007

Study Start

July 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

April 22, 2013

Results First Posted

December 22, 2009

Record last verified: 2013-04

Locations

US(3)AR(1)