NCT00577837

Brief Summary

A Multi-center, Active-controlled (5 mg daily risedronate), Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly for Six Months in Postmenopausal Women with Low Bone Mineral Density.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
370

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2004

Shorter than P25 for phase_2

Geographic Reach
5 countries

14 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

April 1, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
2.6 years 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
Last Updated

April 17, 2013

Status Verified

April 1, 2013

Enrollment Period

1.2 years

First QC Date

December 19, 2007

Last Update Submit

April 15, 2013

Conditions

Postmenopausal

Outcome Measures

Primary Outcomes (1)

  • Evaluate the safety of 3 once-monthly dosing regimens of risedronate, 100 mg, 150 mg and 200 mg, compared to a once-daily dosing regimen, 5 mg, as assessed by clinical laboratory values and adverse event (AE) profiles

    6 months

Secondary Outcomes (1)

  • Evaluate the efficacy of 3 once-monthly dosing regimens or risedronate compared to a once-daily dosing regimen and to evaluate the PK/PD of monthly and daily dose regimens

    6 months

Study Arms (4)

1

ACTIVE COMPARATOR

5 mg risedronate, once daily for 6 months

Drug: risedronate

2

EXPERIMENTAL

100 mg risedronate, once a month for 6 months

Drug: risedronate

3

EXPERIMENTAL

150 mg risedronate, once a month for 6 months

Drug: risedronate

4

EXPERIMENTAL

200 mg risedronate, once a month for 6 months

Drug: experimental

Interventions

risedronateDRUG

tablet, 5 mg risedronate daily for 6 months

1
experimentalDRUG

tablet, 200 mg risedronate monthly for 6 months

4

Eligibility Criteria

Age50 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be postmenopausal 5 years based on medical history; follicle stimulating hormone and estradiol will be evaluated for any patient less than 65 years of age, who has undergone hysterectomy without bilateral oophorectomy, to ensure the patient is postmenopausal

You may not qualify if:

  • use of any of the following medications within 3 months of starting study drug or use of any of the following medications for more than 1 month at any time within 6 months prior to starting study drug:
  • oral or parenteral glucocorticoids (5 mg prednisone or equivalent per day)
  • anabolic steroids
  • estrogen, raloxifene or estrogen-related drugs, eg, tamoxifen, tibolone, (except for low dose vaginal creams, tablets or insertable estrogen ring
  • progestogen
  • calcitonin
  • vitamin D supplements (greater than 800 IU per day)
  • calcitriol, calcidiol, or alfacalcidol
  • any bisphosphonate
  • fluoride (10 mg per day)
  • strontium and other bone active agents
  • parathyroid hormone
  • heparin, warfarin, and other similar anticoagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Research Site

Daytona Beach, Florida, United States

Location

Research Site

Gainesville, Florida, United States

Location

Research Site

Shawnee Mission, Kansas, United States

Location

Research Site

San Antonio, Texas, United States

Location

Research Site

Hamilton, Ontario, Canada

Location

Research Facility

Montreal, Quebec, Canada

Location

Research Facility

Sainte-Foy, Quebec, Canada

Location

Research Facility

Zagreb, Croatia

Location

Research Facility

Amsterdam, Netherlands

Location

Research Facility

Leiden, Netherlands

Location

Research Facility

Bialystok, Poland

Location

Research Site

Lublin, Poland

Location

Research Site

Warsaw, Poland

Location

Research Site

Wroclaw, Poland

Location

MeSH Terms

Interventions

Risedronic Acid

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • John Beary, MD

    Procter and Gamble

    STUDY DIRECTOR

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

April 1, 2004

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

April 17, 2013

Record last verified: 2013-04

Locations

US(4)PL(4)CA(3)NL(2)CR(1)