Atenolol for the Prevention of Osteoporosis (APO) (NCT04905277) | Clinical Trial Compass
CompletedPhase 2
Atenolol for the Prevention of Osteoporosis (APO)
United States420 participantsStarted 2021-07-27
Plain-language summary
Evaluate whether treatment with a widely used beta blocker, atenolol, will prevent bone loss at the lower back and hip in postmenopausal women.
Who can participate
Age range50 Years – 75 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Able and willing to provide informed consent
* Postmenopausal women (FSH ≥ 16 IU/L) (no menses for at least one year)
* Aged 50-75 years
Exclusion Criteria:
* Clinical diagnosis of diabetes mellitus requiring insulin
* Clinically significant abnormality in any of the additional screening laboratory studies
* A1c- ≥8
* Calcium - \> upper limit lab value per site
* AST- 2x upper normal limit
* FSH- \< 16IU/L
* eGFR- \< 45 mL/min/1.73m2 based on creatinine
* CBC- Per PI interpretation of each patient
* Presence of (documented clinical diagnosis of any of the following):
* Significant liver or renal disease
* Malignancy (current diagnosis including myeloma or melanoma)
* Radiation (the site PI will determine eligibility on a case-by-case basis)
* Malabsorption (current clinical diagnosis or actively receiving treatment)
* Hypoparathyroidism (current clinical diagnosis or actively receiving treatment)
* Hyperparathyroidism (current clinical diagnosis or actively receiving treatment)
* Acromegaly
* Cushing syndrome
* Hypopituitarism
* Severe chronic obstructive pulmonary disease
* Pheochromocytoma (current clinical diagnosis or actively receiving treatment)
* History of cardiac failure
* Ejection Fraction \<35% (based on most recent EF within the last 12 months, if available)
* PR interval \> 200 msec on screening ECG or known heart block
* History of bronchospastic disease with treatment (asthma, bronchitis)
* Gastric Bypas…
What they're measuring
1
Primary Outcome: Percent change in total hip bone mineral density (BMD)