Current partner codePEPTIDESDE
NCT01343004·Phase 3·INTERVENTIONAL

Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women

Status

Completed

Phase

Phase 3

Enrollment

2,463

Locations

28

Results

Posted

Publications

11

Study summary

What the protocol is testing.

The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures.

Full detailed description

This is a randomized, double-blind, placebo-controlled, comparative Phase 3, multicenter international study to evaluate the efficacy and safety of BA058 (abaloparatide) 80 µg in the prevention of fracture in otherwise healthy ambulatory postmenopausal women with severe osteoporosis.

Interventions

Treatment arms and agents.

DRUG

Placebo

Placebo 0 mcg subcutaneous daily

DRUG

BA058 80 mcg

BA058 80 mcg subcutaneous daily

DRUG

teriparatide

teriparatide 20 mcg subcutaneous daily

Timeline

From registration to results.

  1. First posted

    Apr 27, 2011

  2. Study start

    Apr 2011

  3. Primary completion

    Oct 2014

  4. Study completion

    Oct 2014

  5. Results posted

    Mar 1, 2017

  6. Registry updated

    Mar 1, 2017

Outcomes

What the study measures.

Primary outcomes

Number of Participants With New Vertebral Fractures at 18 Months

Time frame · 18 months

Secondary outcomes

Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months

Time frame · Basline and 18 months

Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18

Time frame · Baseline and 18 months

Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18

Time frame · Baseline and 18 months

Number of Participants With Non-vertebral Fractures at 18 Months

Time frame · 18 months

Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months

Time frame · 18 months

Eligibility

Who can take part.

Minimum age
50 Years
Maximum age
85 Years
Sex
FEMALE
Healthy volunteers
No

Inclusion Criteria: * Healthy ambulatory postmenopausal (≥ 5 years) women from 50 to 85 years of age (inclusive) with a diagnosis of osteoporosis * The women are to have a bone mineral density (BMD) T score ≤ -2.5 and \> -5.0 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures, or history of low trauma forearm, humerus, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years. Postmenopausal women older than 65 who meet the above fracture criteria but have a T score ≤ -2.0 and \> -5.0 may be enrolled. Women older than 65 who do not meet the fracture criteria may also be enrolled if their T score is ≤ -3.0 and \> -5.0 * Normal physical exam, vital signs, electrocardiogram (ECG) and medical history * Laboratory tests within the normal range including serum calcium, PTH(1-84), serum phosphorus and alkaline phosphatase Exclusion Criteria: * History of more than 4 mild or moderate spine fractures or any severe fracture * Abnormality of the spine or hip that would prohibit assessment of bone mineral density (BMD) * Unexplained elevation of serum alkaline phosphatase, history of bone disorders (such as Paget's disease) or a diagnosis of cancer within the last 5 years (with the exception of basal cell or squamous cancer of the skin) * History of thyroid, parathyroid, or adrenal disorders, or malabsorptive syndromes or any chronic or recurrent diseases or disturbances that would interfere with the interpretation of study data or compromise the safety of the patient * Prior treatment with parathyroid hormone (PTH) or parathyroid hormone-related peptid (PTHrP) * Prior treatment with bisphosphonates, fluoride, or strontium within the past five years or treatment with androgens, anabolic steroids, corticosteroids or selective estrogen receptor modulators within the past 12 months (except hormone replacement therapy) * Prior treatment with an investigational drug within the past 12 months * History of nephrolithiasis or urolithiasis within the past five years, or history of osteosarcoma at any time

Study locations

28 registered sites.

Argentina · Brazil · Czechia · Denmark · Estonia · Hong Kong · Lithuania · Poland · Romania · United States. Showing up to 24 locations stored in the fast local snapshot.

Facility not named

Lakewood, Colorado, United States

Facility not named

Miami, Florida, United States

Facility not named

North Miami, Florida, United States

Facility not named

Atlanta, Georgia, United States

Facility not named

Bethesda, Maryland, United States

Facility not named

Buenos Aires, Argentina

Facility not named

Brasília, Brazil

Facility not named

Curitiba, Brazil

Facility not named

Rio de Janeiro, Brazil

Facility not named

São Paulo, Brazil

Facility not named

Vitória, Brazil

Facility not named

Brno, Czechia

Facility not named

Pardubice, Czechia

Facility not named

Prague, Czechia

Facility not named

Aalborg, Denmark

Facility not named

Ballerup Municipality, Denmark

Facility not named

Vejle, Denmark

Facility not named

Tallinn, Estonia

Facility not named

Tartu, Estonia

Facility not named

Hong Kong, Hong Kong

Facility not named

Vilnius, Lithuania

Facility not named

Bialystok, Poland

Facility not named

Katowice, Poland

Facility not named

Kielce, Poland

Publications

Results and literature.

PMID 40786602Sheth NP, Krohn K, Torkelson J, Winzenrieth R, Humbert L, Pearman L, Wang Y, Boxberger JI, Bostrom MP. Abaloparatide effects on BMD in acetabular regions corresponding to DeLee and Charnley zones in women with postmenopausal osteoporosis. Bone Rep. 2025 Jul 19;26:101858. doi: 10.1016/j.bonr.2025.101858. eCollection 2025 Sep.PMID 39999474DeSapri KT, Clarke BL, Kostenuik P, Wang Y, Mitlak BH. Effect of abaloparatide on fracture incidence and bone mineral density in postmenopausal women with osteoporosis at highest risk for fracture. Menopause. 2025 May 1;32(5):388-395. doi: 10.1097/GME.0000000000002516.PMID 36588166Cosman F, Hans D, Shevroja E, Wang Y, Mitlak B. Effect of Abaloparatide on Bone Microarchitecture Assessed by Trabecular Bone Score in Women With Osteoporosis: Post Hoc Analysis of ACTIVE and ACTIVExtend. J Bone Miner Res. 2023 Apr;38(4):464-470. doi: 10.1002/jbmr.4764. Epub 2023 Feb 12.PMID 34231877Hara T, Hijikata Y, Matsubara Y, Watanabe N. Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013424. doi: 10.1002/14651858.CD013424.pub2.PMID 32658264Cosman F, Peterson LR, Towler DA, Mitlak B, Wang Y, Cummings SR. Cardiovascular Safety of Abaloparatide in Postmenopausal Women With Osteoporosis: Analysis From the ACTIVE Phase 3 Trial. J Clin Endocrinol Metab. 2020 Nov 1;105(11):3384-95. doi: 10.1210/clinem/dgaa450.PMID 32513495Saag KG, Williams SA, Wang Y, Weiss RJ, Cauley JA. Effect of Abaloparatide on Bone Mineral Density and Fracture Incidence in a Subset of Younger Postmenopausal Women with Osteoporosis at High Risk for Fracture. Clin Ther. 2020 Jun;42(6):1099-1107.e1. doi: 10.1016/j.clinthera.2020.04.012. Epub 2020 Jun 6.PMID 31674644Leder BZ, Mitlak B, Hu MY, Hattersley G, Bockman RS. Effect of Abaloparatide vs Alendronate on Fracture Risk Reduction in Postmenopausal Women With Osteoporosis. J Clin Endocrinol Metab. 2020 Mar 1;105(3):938-43. doi: 10.1210/clinem/dgz162.PMID 31411768Leder BZ, Zapalowski C, Hu MY, Hattersley G, Lane NE, Singer AJ, Dore RK. Fracture and Bone Mineral Density Response by Baseline Risk in Patients Treated With Abaloparatide Followed by Alendronate: Results From the Phase 3 ACTIVExtend Trial. J Bone Miner Res. 2019 Dec;34(12):2213-2219. doi: 10.1002/jbmr.3848. Epub 2019 Sep 11.PMID 27826127Moreira CA, Fitzpatrick LA, Wang Y, Recker RR. Effects of abaloparatide-SC (BA058) on bone histology and histomorphometry: The ACTIVE phase 3 trial. Bone. 2017 Apr;97:314-319. doi: 10.1016/j.bone.2016.11.004. Epub 2016 Nov 5.PMID 27612281Cosman F, Hattersley G, Hu MY, Williams GC, Fitzpatrick LA, Black DM. Effects of Abaloparatide-SC on Fractures and Bone Mineral Density in Subgroups of Postmenopausal Women With Osteoporosis and Varying Baseline Risk Factors. J Bone Miner Res. 2017 Jan;32(1):17-23. doi: 10.1002/jbmr.2991. Epub 2016 Sep 28.PMID 27533157Miller PD, Hattersley G, Riis BJ, Williams GC, Lau E, Russo LA, Alexandersen P, Zerbini CA, Hu MY, Harris AG, Fitzpatrick LA, Cosman F, Christiansen C; ACTIVE Study Investigators. Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial. JAMA. 2016 Aug 16;316(7):722-33. doi: 10.1001/jama.2016.11136.

Primary links

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Related trials

More studies on Abaloparatide.

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