Comparative Antiresorptive Efficacy Discontinuation of Denosumab

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2023-08-01

Brief Summary

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

Osteoporosis remains a significant healthcare burden for the United States. Current FDA-approved osteoporosis treatments include teriparatide, abaloparatide, bisphosphonates, denosumab, and raloxifene.

Denosumab is a fully human monoclonal antibody that specifically binds to receptor activator of nuclear factor kappa-B ligand (RANKL). Denosumab potently suppresses osteoclastic activity but bone turnover rapidly normalizes and bone turnover marker levels can rebound above baseline levels after the drug is discontinued.

This study will help us determine the optimal duration and relative efficacy of two oral antiresorptive medications that are FDA-approved for treatment of postmenopausal osteoporosis (alendronate and raloxifene) in preventing the rebound increase in bone turnover that occurs after denosumab discontinuation.

Related Clinical Trials

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

Alendronate and/or Parathyroid Hormone for Osteoporosis

NCT00000400

Osteoporosis

COMPLETED PHASE2

Denosumab vs Alendronate After Vertebroplasty

NCT05662358

Denosumab Allergy

UNKNOWN NA

Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis

NCT00926380

Osteoporosis

COMPLETED PHASE2

Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

NCT01750086

Postmenopausal Osteoporosis

COMPLETED PHASE4

Denosumab Versus Bisphosphonates (Alendronate) in GIOP

NCT03005678

Osteoporosis

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, Postmenopausal 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

SINGLE

Outcome Assessors

Study Groups

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

Denosumab and Raloxifene

denosumab and raloxifene

Group Type ACTIVE_COMPARATOR

denosumab

Intervention Type DRUG

denosumab 60 milligrams subcutaneously every 6 months

raloxifene

Intervention Type DRUG

raloxifene 60 milligrams daily

Denosumab and Alendronate

denosumab and alendronate

Group Type ACTIVE_COMPARATOR

denosumab

Intervention Type DRUG

denosumab 60 milligrams subcutaneously every 6 months

alendronate

Intervention Type DRUG

alendronate 70 milligrams weekly

Interventions

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

denosumab

denosumab 60 milligrams subcutaneously every 6 months

Intervention Type DRUG

alendronate

alendronate 70 milligrams weekly

Intervention Type DRUG

raloxifene

raloxifene 60 milligrams daily

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Prolia Fosamax Evista

Eligibility Criteria

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

Inclusion Criteria

* women aged 45+
* postmenopausal
* osteoporotic with high risk of fracture as per National Osteoporosis Foundation guidelines

Exclusion Criteria

* no significant previous use of bone health modifying treatments
* hip fracture within one year of enrollment
* known congenital or acquired bone disease other than osteoporosis
* significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease
* abnormal calcium or parathyroid hormone level
* serum vitamin D \<20 ng/dL
* anemia (hematocrit \<32%)
* history of malignancy (except non-melanoma skin carcinoma)
* excessive alcohol use or substance abuse
* extensive dental work involving extraction or dental implant within the past 6 months or in the upcoming 12 months
* known contraindications to denosumab, alendronate, or raloxifene

Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes