Atenolol for the Prevention of Osteoporosis (APO)

S

Sundeep Khosla, M.D.

Status and phase

Active, not recruiting
Phase 2

Conditions

Healthy

Treatments

Drug: Placebo
Drug: Atenolol 50 MG

Study type

Interventional

Funder types

Other

Identifiers

NCT04905277
18-005725

Details and patient eligibility

About

Evaluate whether treatment with a widely used beta blocker, atenolol, will prevent bone loss at the lower back and hip in postmenopausal women.

Enrollment

420 estimated patients

Sex

Female

Ages

50 to 75 years old

Volunteers

Accepts Healthy Volunteers

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 Bypass
  • Parkinson's
  • Rheumatoid Arthritis
  • Psoriatic Arthritis
  • Connective Tissue disease

Undergoing treatment with any medications that affect bone turnover, including the following:

  • adrenocorticosteroids (oral for > 3 months within the past year or year-round use of inhaled corticosteroid use)
  • anticonvulsant therapy for seizures (carbamazepine, phenobarbital, or phenytoin within the previous year) pharmacological doses of: thyroid hormone (causing decline of thyroid stimulating hormone below normal, i.e. < 0.3 miU/L) bisphosphonates (within the past 3 yrs; if taken orally >1 month in past 3 years) denosumab, romosozumab, estrogen therapy (does not include creams or suppositories) or treatment with a selective estrogen receptor modulator, or teriparatide/abaloparatide (> 1 month within the past year); aromatase inhibitors (>1 month within the past year)
  • Current use of digitalis glycosides
  • Thiazides (< 6 months of use prior to screening)
  • Current or within the past 3 months use of beta blockers
  • Any recent fracture within the past 6 months prior to screening (other than fingers, toes and facial fractures, which are all acceptable)
  • Bilateral hip replacements or metal in both hips
  • Patients with serum 25-hydroxyvitamin D levels of < 20 ng/ml, in order to ensure vitamin D sufficiency
  • Resting systolic blood pressure < 115 mm Hg, heart rate < 55 bpm (average of 3 readings after a 5-minute rest and one minute between readings with an automatic cuff)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

420 participants in 2 patient groups, including a placebo group

Atenolol
Experimental group
Description:
Study subjects will take Atenolol 50 mg daily over 2 years
Treatment:
Drug: Atenolol 50 MG
Placebo
Placebo Comparator group
Description:
Study subjects will take a placebo daily over 2 years
Treatment:
Drug: Placebo

Trial contacts and locations

3

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Central trial contact

Amanda Tweed; Tammie Volkman, RN

Data sourced from clinicaltrials.gov

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