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Could adding a second drug boost bone strength in osteoporosis?

NCT ID NCT04467983

Disease control Sponsor: Hospital for Special Surgery, New York Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looks at whether adding the drug abaloparatide (Tymlos) to the standard treatment denosumab (Prolia) can improve bone density more than denosumab alone in postmenopausal women with osteoporosis. Seventy women who have already been on denosumab will either continue with denosumab alone or add daily abaloparatide injections for 18 months. The main goal is to measure changes in bone density at the hip and spine.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Abaloparatide (Tymlos) added to Denosumab (Prolia)
What this could lead to
If successful, this could show that adding abaloparatide to ongoing denosumab treatment significantly improves bone density in postmenopausal women with osteoporosis, offering a stronger treatment option.
What could go wrong
This is a small, early-phase 4 trial with only 70 participants, so results may not apply to everyone. Adding a daily injection may also increase side effects or be hard for patients to stick with.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * postmenopausal woman \>age 45 of any racial origin * Participants will have received at least 4 prior denosumab treatments and be within 7 months from their last denosumab injection * Participants are willing to participate for the duration of the study and have no physical or psychological illness that would prohibit them from participating. * Diagnosis of osteoporosis based on bone mineral density and/or fracture criteria. Osteoporosis will be defined by bone mineral density T-Score \< -2.5 at lumbar spine (at least 2 evaluable vertebrae between L1 and L4), total hip or femoral neck. Osteoporosis will also be defined clinically in women with osteoporotic fractures within the preceding 5 years, including clinical vertebral or nonvertebral fractures or vertebral fracture confirmed by radiograph or lateral DXA VFA image, along with a DXA BMD T-Score \< -1.5 at one or more skeletal sites. Exclusion Criteria: * Use of drugs other than denosumab (within the preceding 3 months) known to affect skeletal or calcium homeostasis. * Fewer than 2 evaluable lumbar vertebrae * A history of a symptomatic renal stone within the past 2 years or history of multiple symptomatic renal stones within the preceding 10 years * Skeletal Disorders other than osteoporosis, including hypercalcemia, hyperparathyroidism, or Paget's Disease * History of external or internal radiation therapy * Estimated GFR below 30 ml/min * Any contraindications to receipt of Abaloparatide or Denosumab * History of any cancer in past 5 years (except basal/squamous skin cancer) * Unexplained elevation of Serum Alkaline Phosphatase * History of atypical femoral fracture

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Conditions

The condition(s) this trial relates to.

osteoporosis postmenopausal osteoporosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoporosis postmenopausal

Contacts and locations

Locations

  • Hospital for Special Surgery

    New York, New York, 10021, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.