How GLP‑1 weight‑loss drugs affect muscle and bones in midlife women.
GLP-1RA Effects on Lean Mass and Bone Health in Midlife Women
This test will see if starting a GLP‑1RA weight‑loss medication changes lean muscle, strength, and bone health in midlife women (35–60) with higher BMI.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 35 Years to 60 Years |
| Sex | Female |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT07422987 on ClinicalTrials.gov |
What this trial studies
This observational study follows English‑speaking women aged 35–60 who are newly prescribed a GLP‑1RA for weight loss to track body composition, muscle function, and bone health over time. Investigators will measure estrogen levels along with weight, lean mass versus fat mass, and standardized tests of muscle performance and bone health at baseline and during follow‑up visits. Eligible participants have BMI ≥30 or BMI ≥27 plus at least one cardiometabolic risk factor, and women with type 2 diabetes, recent GLP‑1RA discontinuation, pregnancy, certain endocrine or pancreatitis histories, or current aromatase inhibitor/SERM use are excluded. The study is conducted at the University of Kansas Medical Center and does not randomize or assign medications, since participants are newly prescribed GLP‑1RAs as part of routine care.
Who should consider this trial
Good fit: Ideal candidates are English‑speaking women aged 35–60 with BMI ≥30 (or BMI ≥27 plus a cardiometabolic risk factor) who are newly prescribed a GLP‑1RA and have had stable weight for the past six months.
Not a fit: Women with type 2 diabetes, recent GLP‑1RA discontinuation, pregnancy, contraindicating personal or family medical history, current aromatase inhibitor or SERM use, or who cannot consent or read English are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could help clinicians understand whether GLP‑1RA weight‑loss medications preserve or reduce muscle and bone health in midlife women and inform safer treatment choices.
How similar studies have performed: GLP‑1RAs are well documented to cause weight loss, but their specific effects on lean mass and bone in midlife women with varying estrogen levels remain relatively unstudied, so this focus is fairly novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Females * Age 35-60 year * BMI≥30 or BMI≥27 and at least one cardiometabolic risk factor (dyslipidemia, hypertension, obstructive sleep apnea, metabolic syndrome, fatty liver, PCOS) * Newly prescribed a GLP-1RA medication * English speaking * Body weight stable for the past 6 months Exclusion Criteria: * Pregnant women * Under age 35 or over age 60 * Born male * Cannot consent for themselves * Cannot read and speak in English * Type 2 diabetes * Recently discontinued a GLP-1RA medication (less than 6-months since discontinuing) * Contraindications for taking a GLP-1 RA medication (personal or family history of medullary thyroid carcinoma, personal or family history of multiple endocrine neoplasia type 2, personal history of pancreatitis, pregnancy, hypersensitivity to the drug or any component of the drug, active suicidal ideation) * Currently taking aromatase inhibitors or selective estrogen receptor modulators (SERMs)
Where this trial is running
Kansas City, Kansas
- The University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Johanna Finkle, MD — University of Kansas Medical Center
- Study coordinator: Johanna Finkle, MD
- Email: jfinkle2@kumc.edu
- Phone: (913) 588-5478
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.