MedDataX Logo

Analysis of Iliac Crest Biopsies From Patients Receiving Risedronate

NCT ID: NCT00837746

Last Updated: 2013-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-04-30

Study Completion Date

2006-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study analysed and reported on the study data from three similar, risedronate studies, 1996052, 2003073, and 2003096. The objective of the study was to determine the differences in the iliac crest bone histomorphometry and bone quality in postmenopausal women who had received long term therapy with risedronate.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women

NCT00358176

Osteoporosis Postmenopausal
COMPLETED PHASE3

Study of Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Alendronate or Risedronate

NCT00778154

Postmenopausal Osteoporosis
COMPLETED

Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

NCT00353080

Osteoporosis, Postmenopausal
COMPLETED PHASE3

Bone Microarchitecture in Osteopenic Postmenopausal Women

NCT00577395

Osteoporosis
TERMINATED PHASE4

Risedronate in the Prevention of Osteoporosis in Postmenopausal Women

NCT00402441

Osteoporosis, Postmenopausal
COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Women taking risedronate for 5 years

risedronate

Intervention Type DRUG

risedronate tablet, 5 mg daily or 35 mg once weekly for 5 years

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

risedronate

risedronate tablet, 5 mg daily or 35 mg once weekly for 5 years

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Completed month 36 of Study RVN-008993.
* Underwent an iliac crest bone biopsy at month 36.

Exclusion Criteria

* Was less than 60% compliant with regard to taking study drug from the start of the study drug to month 24 of study RVN-008993.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanofi

INDUSTRY

Sponsor Role collaborator

Warner Chilcott

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ana M Balske, MD

Role: STUDY_DIRECTOR

Procter and Gamble

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Maria Greenwald, MD

Palm Desert, California, United States

Site Status

Paul Miller, MD

Lakewood, Colorado, United States

Site Status

Grattan Woodson, MD

Decatur, Georgia, United States

Site Status

Christopher Recknor, MD

Gainesville, Georgia, United States

Site Status

Robert Recker, MD

Omaha, Nebraska, United States

Site Status

Nelson Watts, MD

Cincinnati, Ohio, United States

Site Status

Ronald D Emkey, MD

Wyomissing, Pennsylvania, United States

Site Status

Louis-Georges Ste-Marie, MD

Montreal, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2004140

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study to Assess the Bioequivalence of Different Formulations of Risedronate in Healthy Male and Female Subjects
NCT00846196 COMPLETED PHASE1
A Study of Monthly Risedronate for Osteoporosis
NCT00247273 COMPLETED PHASE3
Risedronate in Postmenopausal Women With Low Bone Density
NCT00351091 COMPLETED PHASE2
Risedronate in Osteopenic Postmenopausal Women
NCT00345644 COMPLETED PHASE3
Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD
NCT00577837 COMPLETED PHASE2
Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis
NCT00619957 COMPLETED PHASE3
Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO
NCT00577421 COMPLETED PHASE3
A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis
NCT00541658 COMPLETED PHASE3
A Study to Determine the Satisfaction With Actonel in Postmenopausal Women With Osteoporosis
NCT00632216 COMPLETED PHASE4
Satisfaction and Compliance of Risedronate in PMO
NCT00549965 COMPLETED PHASE4
Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover
NCT01249261 COMPLETED PHASE3
Study to Assess Efficacy of Risedronate in Preventing Bone Loss in Postmenopausal Women Treated for Breast Cancer
NCT00859703 COMPLETED PHASE3
Risedronate vs Raloxifene in Hormone Replacement Therapy Discontinuation
NCT00790101 TERMINATED PHASE4
Risedronate Sodium in Post Menopausal Osteoporosis
NCT00453492 COMPLETED PHASE4
Assess Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets in Healthy Subjects
NCT00699777 COMPLETED PHASE1
Study of the Effect of Once a Week Risedronate on the Microstructure of Tibia and Radius Using a New Scanning Method
NCT00386360 COMPLETED PHASE3
Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty
NCT00772395 COMPLETED PHASE4
Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women
NCT00918749 COMPLETED PHASE2
Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women
NCT00372099 COMPLETED PHASE3
Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women
NCT00927186 COMPLETED PHASE4
CR9112792, a Follow-up of Study CR9108963
NCT00891553 COMPLETED
Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis
NCT00405392 COMPLETED PHASE4
Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate
NCT00577720 COMPLETED PHASE2
Long Term Effects of Raloxifene Treatment on Bone Quality
NCT00532428 COMPLETED PHASE4
Pharmacokinetics of a Single 14C-labeled Dose of Risedronate or Alendronate Followed by Once-a-week Unlabeled Oral Dose
NCT00577850 COMPLETED PHASE1