NCT00577720

Brief Summary

To compare the efficacy 50 mg delayed-release risedronate tablet, dosed immediately after breakfast, to a 35 mg immediate-release tablet, administered according to labeling instructions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
181

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

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

Study Start

First participant enrolled

July 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
12 months until next milestone

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
4.1 years until next milestone

Results Posted

Study results publicly available

January 13, 2012

Completed
Last Updated

January 13, 2012

Status Verified

November 1, 2011

Enrollment Period

6 months

First QC Date

December 19, 2007

Results QC Date

August 12, 2011

Last Update Submit

December 6, 2011

Conditions

Postmenopausal Women

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population

    Baseline and Week 13

Secondary Outcomes (2)

  • Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population

    Baseline and Week 13

  • Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population

    Baseline and Week 13

Study Arms (4)

35 mg IRBB

ACTIVE COMPARATOR

35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks

Drug: risedronate

35 mg DRFB

EXPERIMENTAL

35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks

Drug: risedronate

50 mg DRFB

EXPERIMENTAL

50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks

Drug: risedronate

50 mg DRBB

EXPERIMENTAL

50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks

Drug: risedronate

Interventions

risedronateDRUG

35mg immediate release risedronate tablet before breakfast, once a week for 13 weeks

35 mg IRBB

Eligibility Criteria

Age45 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In generally good health, as determined by medical history, physical examination, and laboratory test results
  • Postmenopausal greater than 2 years, naturally or surgically based on medical history.

You may not qualify if:

  • Used any of the following medications within 3 months prior to dosing or used any of the following medications for more than 1 month at any time within 6 months prior to dosing:
  • oral or parenteral glucocorticoids (5 mg prednisone or equivalent/day)
  • anabolic steroids
  • estrogens (oral, skin patch, or gel), except for low dose vaginal products or insertable estrogen ring, selective estrogen-receptor modulators, or estrogen-related drugs
  • progestins
  • calcitonin
  • vitamin D supplements
  • calcitriol, calcidiol, or alfacalcidol at any dose
  • any bisphosphonate
  • fluoride
  • strontium
  • parathyroid hormone, including teriparatide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Research Facility

Costa Mesa, California, 92626, United States

Location

Research Facility

Gainsville, Florida, 32608, United States

Location

Research Facility

Miami, Florida, 33126, United States

Location

Research Facility

Honolulu, Hawaii, 86813, United States

Location

Research Site

Dallas, Texas, 75247, United States

Location

Research Facility

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

Risedronic Acid

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

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

Study Officials

  • Lu A Sun, MD, PhD

    Procter and Gamble

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
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, 2006

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

January 13, 2012

Results First Posted

January 13, 2012

Record last verified: 2011-11

Locations

US(6)