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New treatment option for Osteoporosis, Postmenopausal
Official title Mechanisms of Anabolic Osteoporosis Therapy
ClinicalTrials.gov ID: NCT05688969
What this study is testing
- What it's testing
- The aim of this study is to investigate the effect of romosozumab on bone cells during early and late phases of treatment.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older, women only
You may be able to join if
- All postmenopausal women who are prescribed romosozumab by their treating physicians, meet the FDA-defined indication for romosozumab, and who are...
- Female aged \> 45 years
- Postmenopausal by either of the following criteria:
- \> 36 since last spontaneous menses
- \> 36 months since hysterectomy, plus serum FSH \> 40 units / liter if \< 60 years
You likely can't join if
- renal disease (stage 4 CKD)
- elevated blood PTH (intact PTH \> 77 pg/ml).
- serum 25-OH vitamin D \< 20 ng/ml
- major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing...
- excessive alcohol use or substance abuse that would preclude the subject from providing adequate informed consent or completing the protocol...
- known congenital or acquired bone disease other than osteoporosis.
See the full eligibility criteria
- All postmenopausal women who are prescribed romosozumab by their treating physicians, meet the FDA-defined indication for romosozumab, and who are not at increased risk for a bone marrow aspirate or bone biopsy will be...
- Female aged \> 45 years
- Postmenopausal by either of the following criteria:
- \> 36 since last spontaneous menses
- \> 36 months since hysterectomy, plus serum FSH \> 40 units / liter if \< 60 years
- renal disease (stage 4 CKD)
- elevated blood PTH (intact PTH \> 77 pg/ml).
- serum 25-OH vitamin D \< 20 ng/ml
- major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
- excessive alcohol use or substance abuse that would preclude the subject from providing adequate informed consent or completing the protocol procedures.
- known congenital or acquired bone disease other than osteoporosis.
- exposure to oral bisphosphonates within the past 3 months, denosumab in the last 12 months, intravenous bisphosphonates within the past 24 months.
- exposure to estrogens, SERMs, or calcitonin, oral or parenteral glucocorticoids for more than 14 days in the past 2 months.
- any prior exposure to romosozumab.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.