Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-07-31

Brief Summary

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

This is a pilot study evaluating the recruitment strategies for sites and patients, data collection instruments, follow-up procedures, administrative processes, and the proposed management strategy for the future large scale national trial.

Related Clinical Trials

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

A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211)

NCT00092014

Postmenopausal Osteoporosis

COMPLETED PHASE3

Alendronate Prevents Microarchitectural Deterioration of Trabecular Bone in Early Postmenopausal Women

NCT00504166

Osteopenia Osteoporosis

COMPLETED PHASE4

A Clinical Study on the Effect of Discontinuing Alendronate in Postmenopausal Women With Osteoporosis After a Treatment Period Without Fractures

NCT06864130

Osteoporosis in Post-menopausal Women

RECRUITING PHASE4

Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

NCT00136058

Osteoporosis

COMPLETED PHASE3

PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis

NCT00005005

Osteoporosis

COMPLETED PHASE2

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 Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Continuation Arm

Alendronate continuation arm

Group Type ACTIVE_COMPARATOR

Alendronate

Intervention Type DRUG

Discontinuation Arm

Alendronate discontinuation arm

Group Type ACTIVE_COMPARATOR

Alendronate

Intervention Type DRUG

Interventions

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

Alendronate

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

1.Females 65+

2.3+ years of alendronate (Fosamax/Binosto) use

3\. Valid social security number

Exclusion Criteria

1. History of any other metabolic bone condition, such as Paget Disease of Bone
2. Currently receiving treatment for ongoing cancer, excluding non-melanoma skin cancer.
3. Has significant underlying illness that would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 3 years)?
4. HIV positive
5. Involved in a conflicting (investigational drug) clinical trial

Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No