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Monoclonal Antibodies

Denosumab and Raloxifene for Osteoporosis

Phase 4

Waitlist Available

Led By Joy Tsai, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

postmenopausal

osteoporotic with high risk of fracture as per National Osteoporosis Foundation guidelines

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 24 to 36 months

Awards & highlights

Study Summary

This trial will help us determine the best way to use two existing osteoporosis treatments to prevent bone loss after stopping use of denosumab.

Eligible Conditions

Osteoporosis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

You are past menopause.

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You have a high risk of bone fractures due to osteoporosis, according to the guidelines of the National Osteoporosis Foundation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 24 to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 24 to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 24 to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bone mineral density (BMD)

Serum c-telopeptide (CTX)

Trial Design

2Treatment groups

Active Control

Group I: Denosumab and RaloxifeneActive Control2 Interventions

denosumab and raloxifene

Group II: Denosumab and AlendronateActive Control2 Interventions

denosumab and alendronate

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,304 Total Patients Enrolled

19 Trials studying Osteoporosis

1,274 Patients Enrolled for Osteoporosis

Joy Tsai, MDPrincipal Investigator - MGH

Massachusetts General Hospital, Nantucket Cottage Hospital

Northwestern University Medical Sch (Medical School)

1 Previous Clinical Trials

18 Total Patients Enrolled

1 Trials studying Osteoporosis

18 Patients Enrolled for Osteoporosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent have Denosumab and Raloxifene been evaluated during prior clinical investigations?

"At present, 58 separate investigations into both Denosumab and Raloxifene are running concurrently; 14 of them have advanced to the third stage. Primarily based in Douliu, Yunlin County, these experiments span 488 individual sites."

Answered by AI

Are there still opportunities to volunteer for this clinical trial?

"The trial's details hosted on clinicaltrials.gov reveal that this medical experiment is not seeking any more participants at the moment, though it was initially posted in November of 2018 and last updated in June 2022. On the bright side, 196 other trials are currently looking for volunteers to join them."

Answered by AI

Are Denosumab and Raloxifene treatments safe for patients to utilize?

"There is ample evidence of safety regarding Denosumab and Raloxifene, making it eligible for a score of 3 on the 1-3 scale."

Answered by AI

To what medical issues are Denosumab and Raloxifene frequently used to treat?

"Denosumab and Raloxifene are generally prescribed as a means of treating malignant neoplasms, whilst also being able to help those impacted by conditions like osteoporosis, postmenopausal symptoms, and other androgen-mediated diseases."

Answered by AI

How many participants are being accepted into this medical experiment?

"Currently, this trial is not accepting new patient applications. Initially posted on November 30th 2018 and last updated June 5th 2022, the study has concluded recruitment for now. If you are still seeking medical studies to participate in, there are 138 trials focused on osteoporosis that are presently enrolling patients as well as 58 investigations involving Denosumab and Raloxifene with open enrolment periods."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparative Antiresorptive Efficacy Discontinuation of Denosumab

Joy Tsai 2018. "Comparative Antiresorptive Efficacy Discontinuation of Denosumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03623633.