HealthyPhase 2APONCT04905277
Atenolol for the Prevention of Osteoporosis (APO)
A Phase 2 study testing Atenolol 50 MG in people with Healthy, run by Sundeep Khosla, M.D. at 3 sites in United States.
Trial summary
Evaluate whether treatment with a widely used beta blocker, atenolol, will prevent bone loss at the lower back and hip in postmenopausal women. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Atenolol 50 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Jul 2021to 2 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able and willing to provide informed consent
- Postmenopausal women (FSH ≥ 16 IU/L) (no menses for at least one year)
- Aged 50-75 years
Who cannot join
- 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
Show all 39Show fewer
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Columbia University Irving Medical Center
New York, New York, 10032
Mayo Clinic
Rochester, Minnesota, 55905
MaineHealth
Scarborough, Maine, 04074
About this study
Official title: Beta1-Selective Blockade for Prevention of Postmenopausal Bone Loss: A Phase 2, Multi-Center, Double-Blinded, Randomized Placebo-Controlled Trial
Evaluate whether treatment with a widely used beta blocker, atenolol, will prevent bone loss at the lower back and hip in postmenopausal women.
- Conditions
- Healthy
- Being tested
- Atenolol 50 MG, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atenolol 50 MGDrug
Also called Atenolol
50 mg Atenolol daily
PlaceboDrug
one placebo daily
| Study group | Role | What they receive |
|---|---|---|
| Atenolol | Experimental | Study subjects will take Atenolol 50 mg daily over 2 years Receives: Drug: Atenolol 50 MG |
| Placebo | Placebo comparator | Study subjects will take a placebo daily over 2 years Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome: Percent change in total hip bone mineral density (BMD)
Percent change in total hip bone mineral density (BMD) by DXA
Measured: Baseline, 24 months
Secondary outcomes (2)
Secondary Outcomes: Percent changes in lumbar spine and femur neck BMD
Percent changes in lumbar spine and femur neck BMD
Measured: Baseline, 24 months
Additional secondary outcomes
Percent changes in radius and ultra-distal radius BMD using DXA and in bone turnover markers (CTx, PINP).
Measured: Baseline, intermediate timepoints, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start27 Jul 2021
- Primary completion2 Feb 2026
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Atenolol vs. Placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sundeep Khosla, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, MaineHealth, University of California, San Francisco
- Responsible party
- Sponsor-investigator, Sundeep Khosla, M.D., Mayo Clinic
- Investigators
- Sundeep Khosla, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905277
- Sponsor's protocol ID
- 18-005725
- Acronym
- APO
- Status last verified
- May 2026
- First submitted
- 24 May 2021
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta1-Selective Blockade for Prevention of Postmenopausal Bone Loss: A Phase 2, Multi-Center, Double-Blinded, Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT04905277
- Acronym / sponsor ID
- APO / 18-005725
- Conditions
- Healthy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Sundeep Khosla, M.D.University, hospital or other
- Collaborators
- Columbia University, MaineHealth, University of California, San Francisco
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate whether treatment with a widely used beta blocker, atenolol, will prevent bone loss at the lower back and hip in postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Atenolol vs. Placebo
| Arm | Type | Receives |
|---|---|---|
| Atenolol | Experimental | Drug: Atenolol 50 MGStudy subjects will take Atenolol 50 mg daily over 2 years |
| Placebo | Placebo comparator | Drug: PlaceboStudy subjects will take a placebo daily over 2 years |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able and willing to provide informed consent
- Postmenopausal women (FSH ≥ 16 IU/L) (no menses for at least one year)
- Aged 50-75 years
Key exclusion criteria (39 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atenolol 50 MGAlso: Atenolol50 mg Atenolol daily | Drug | Atenolol |
| Placeboone placebo daily | Drug | Placebo |
Primary outcome
Primary Outcome: Percent change in total hip bone mineral density (BMD)
Time frame: Baseline, 24 months
Percent change in total hip bone mineral density (BMD) by DXA
2 secondary outcomes
Secondary Outcomes: Percent changes in lumbar spine and femur neck BMD
Time frame: Baseline, 24 months
Additional secondary outcomes
Time frame: Baseline, intermediate timepoints, 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sundeep Khosla, MD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atenolol 50 MG in people with Healthy, run by Sundeep Khosla, M.D. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome: Percent change in total hip bone mineral density (BMD) (time frame: Baseline, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.