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Osteoporosis Agent

Abaloparatide + Denosumab for Osteoporosis

Phase 4

Recruiting

Research Sponsored by Hospital for Special Surgery, New York

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants will have received at least 4 prior denosumab treatments and be within 7 months from their last denosumab injection

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

Must not have

Skeletal Disorders other than osteoporosis, including hypercalcemia, hyperparathyroidism, or Paget's Disease

History of external or internal radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, 12, 18 months

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare the effects of two different treatments on postmenopausal women's bone mineral density over 18 months. The primary outcome will be group differences in bone mineral density of the total hip and lumbar spine at 18 months.

Who is the study for?

This trial is for postmenopausal women over 45 who have osteoporosis, defined by a bone density T-Score < -2.5 or fractures in the last 5 years with a T-Score < -1.5. They must have had at least 4 prior denosumab injections and be within 7 months of their last shot, willing to participate throughout the study without any condition that would prevent them.

What is being tested?

The trial compares two treatments: continued denosumab alone versus adding abaloparatide to denosumab for 18 months among 70 participants. It will measure changes in bone mineral density at various sites and times, as well as bone turnover markers like PINP and CTX levels.

What are the potential side effects?

Possible side effects include skin irritation at injection sites, low calcium levels (hypocalcemia), muscle spasms or cramps, dizziness or fainting due to low blood pressure after injection (orthostatic hypotension), nausea or headache.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had at least 4 denosumab injections and my last one was within the past 7 months.

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I have been diagnosed with osteoporosis, either through a bone density test or because of a fracture.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have bone disorders like hypercalcemia, hyperparathyroidism, or Paget's Disease.

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I have undergone radiation therapy before.

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I have had a painful kidney stone in the last 2 years or multiple ones in the last 10 years.

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My kidney function is severely reduced.

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I have less than 2 evaluable lumbar vertebrae.

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I have no allergies or conditions that prevent me from taking Abaloparatide or Denosumab.

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I have not had any cancer except for skin cancer in the last 5 years.

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I have had an unusual fracture in my thigh bone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, 12, 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, 12, 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 12, 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bone mineral density changes at total hip and lumbar spine

Secondary study objectives

Bone mineral density changes in increments

Differences in biochemical bone turnover markers

Trabecular Bone Score changes

+1 more

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: Denosumab aloneActive Control1 Intervention

3 injections of Denosumab at appropriate times, separated by no more than 7 months from the last treatment.

Group II: Combination therapyActive Control2 Interventions

3 injections of Denosumab at appropriate times, separated by no more than 7 months from the last treatment, with added abaloparatide 80 mcg subcutaneously daily, started within 6 months of the last denosumab treatment, for a total of 18 months.

0 / 10Eligibility criteria met