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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

Must not have

Any prior exposure to romosozumab

Renal disease (stage 4 CKD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-6 weeks (early) versus 6-8 months (late)

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I am postmenopausal, with no period for over 3 years or had a hysterectomy with high FSH levels if I'm under 60.

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I am eligible for romosozumab treatment according to FDA guidelines.

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I am a woman older than 45 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously been treated with romosozumab.

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I have stage 4 chronic kidney disease.

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I have a bone condition that is not osteoporosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-6 weeks (early) versus 6-8 months (late)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Osteoblast progenitor cell numbers

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 6Eligibility criteria met