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Monoclonal Antibodies

Anabolic Therapy Timing for Osteoporosis

N/A
Recruiting
Led By Benjamin Leder, 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 by either of the following criteria: > 36 months since last spontaneous menses or > 36 months since hysterectomy, plus serum FSH > 40 units / liter if < 60 years
Meet the FDA-defined indication for romosozumab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-6 weeks (early) versus 6-8 months (late)
Awards & highlights

Study Summary

This trial studies how a drug affects bones in the short and long term.

Who is the study for?
This trial is for postmenopausal women over 45 with osteoporosis who are not at high risk for bone procedures and have been prescribed romosozumab. They mustn't have other bone diseases, recent use of certain hormones or steroids, major psychiatric conditions, low vitamin D levels, high PTH levels, prior romosozumab exposure, substance abuse issues, or severe kidney disease.Check my eligibility
What is being tested?
The study examines the effects of a medication called romosozumab on bone cells in women with osteoporosis. It compares results from early versus late treatment phases to understand how this drug works over time.See study design
What are the potential side effects?
While the specific side effects aren't listed here, generally speaking, treatments like romosozumab can cause reactions at the injection site, muscle pain or cramps; it may also affect calcium levels leading to tingling sensations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am postmenopausal, with no period for over 3 years or had a hysterectomy with high FSH levels if I'm under 60.
Select...
I am eligible for romosozumab treatment according to FDA guidelines.
Select...
I am a woman older than 45 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-6 weeks (early) versus 6-8 months (late)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-6 weeks (early) versus 6-8 months (late) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Osteoblast progenitor cell numbers

Trial Design

2Treatment groups
Active Control
Group I: Late BiopsyActive Control1 Intervention
The investigators will perform paired iliac crest bone biopsies in postmenopausal women who meet standard romosozumab treatment indications and are being prescribed romosozumab by their treating physician. All study volunteers will have a bone biopsy procedure prior to starting therapy, and then an identical procedure at the contralateral side either 3-6 weeks ("early") or 6-8 months ("late") after starting therapy. This is not a clinical trial: the investigators will not be assigning volunteers to a specific osteoporosis therapy, though the investigators will randomize volunteers to either the early or late second biopsy.
Group II: Early BiopsyActive Control1 Intervention
The investigators will perform paired iliac crest bone biopsies in postmenopausal women who meet standard romosozumab treatment indications and are being prescribed romosozumab by their treating physician. All study volunteers will have a bone biopsy procedure prior to starting therapy, and then an identical procedure at the contralateral side either 3-6 weeks ("early") or 6-8 months ("late") after starting therapy. This is not a clinical trial: the investigators will not be assigning volunteers to a specific osteoporosis therapy, though the investigators will randomize volunteers to either the early or late second biopsy.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,625 Total Patients Enrolled
19 Trials studying Osteoporosis
1,309 Patients Enrolled for Osteoporosis
Benjamin Leder, MDPrincipal InvestigatorMass General Brigham
3 Previous Clinical Trials
163 Total Patients Enrolled
3 Trials studying Osteoporosis
163 Patients Enrolled for Osteoporosis

Media Library

Romosozumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05688969 — N/A
Osteoporosis Research Study Groups: Late Biopsy, Early Biopsy
Osteoporosis Clinical Trial 2023: Romosozumab Highlights & Side Effects. Trial Name: NCT05688969 — N/A
Romosozumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05688969 — N/A

Frequently Asked Questions

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

Is this research endeavor currently accepting participants?

"Affirmative. Clinicaltrials.gov's records demonstrate that this clinical study, which was posted on June 14th 2023, is actively seeking enrolment of 16 patients from a single site. It has been most recently updated on August 17th 2023."

Answered by AI

What is the upper limit for individuals involved in this research project?

"Yes, the clinicaltrials.gov page attests to this study's active recruitment efforts - it was first posted on June 14th 2023 and recently updated on August 17th 2023. This trial requires 16 participants from a single research centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Mechanisms of Anabolic Osteoporosis Therapy
Benjamin Leder, MD 2023. "Mechanisms of Anabolic Osteoporosis Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05688969.
All > Osteoporosis Boston > Osteoporosis
~11 spots leftby Feb 2028
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