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

NCT01343004 | Completed Phase 3 Results DMC

• 2 other identifiers: BA058-05-003ACTIVE Trial
• Study Type: interventional
• Target: 2,463
• Locations: 10 countries
• Sites: 28

Brief Summary

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.

Conditions

Osteoporosis; Postmenopausal Osteoporosis

Keywords

BA058; abaloparatide; Abaloparatide-SC; osteoporosis; postmenopausal; bone loss; ACTIVE; fracture

Outcome Measures

Primary Outcomes (1)

• Number of Participants With New Vertebral Fractures at 18 Months

  18 months

Secondary Outcomes (5)

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

  Basline and 18 months

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

  Baseline and 18 months

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

  Baseline and 18 months

• Number of Participants With Non-vertebral Fractures at 18 Months

  18 months

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

  18 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo identical in appearance to BA058 study drug

Drug: Placebo

BA058 80 mcg (abaloparatide)

EXPERIMENTAL

Drug: BA058 80 mcg

teriparatide

ACTIVE COMPARATOR

Blinded until after randomization, then open-label

Drug: teriparatide

Interventions

Placebo DRUG

Placebo 0 mcg subcutaneous daily

Placebo

BA058 80 mcg DRUG

BA058 80 mcg subcutaneous daily

Also known as: abaloparatide, Abaloparatide-SC

BA058 80 mcg (abaloparatide)

teriparatide DRUG

teriparatide 20 mcg subcutaneous daily

Also known as: Forteo, Forsteo

teriparatide

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radius Health, Inc.: lead

Study Sites (28)

Unknown Facility

Lakewood, Colorado, United States

Location

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Miami, Florida, United States

Location

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North Miami, Florida, United States

Location

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Atlanta, Georgia, United States

Location

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Bethesda, Maryland, United States

Location

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Buenos Aires, Argentina

Location

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Brasília, Brazil

Location

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Curitiba, Brazil

Location

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Rio de Janeiro, Brazil

Location

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São Paulo, Brazil

Location

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Vitória, Brazil

Location

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Brno, Czechia

Location

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Pardubice, Czechia

Location

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Prague, Czechia

Location

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Aalborg, Denmark

Location

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Ballerup Municipality, Denmark

Location

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Vejle, Denmark

Location

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Tallinn, Estonia

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Tartu, Estonia

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Hong Kong, Hong Kong

Location

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Vilnius, Lithuania

Location

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Bialystok, Poland

Location

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Katowice, Poland

Location

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Kielce, Poland

Location

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Lodz, Poland

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Warsaw, Poland

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Zgierz, Poland

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Bucharest, Romania

Location

Related Publications (11)

• Sheth 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: 40786602 DERIVED

• DeSapri 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: 39999474 DERIVED

• Cosman 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: 36588166 DERIVED

• Hara 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: 34231877 DERIVED

• Cosman 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: 32658264 DERIVED

• Saag 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: 32513495 DERIVED

• Leder 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: 31674644 DERIVED

• Leder 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: 31411768 DERIVED

• Moreira 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: 27826127 DERIVED

• Cosman 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: 27612281 DERIVED

• Miller 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.

  PMID: 27533157 DERIVED

MeSH Terms

Conditions

Osteoporosis; Osteoporosis, Postmenopausal; Bone Diseases, Metabolic; Motor Activity; Fractures, Bone

Interventions

abaloparatide; Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Program Director
• Organization: Radius Health, Inc.

info@radiuspharm.com

(617) 551-4700

Study Officials

• Radius Health, Inc.

  Radius Health, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2011
• First Posted: April 27, 2011
• Study Start: April 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 1, 2017
• Results First Posted: March 1, 2017

Record last verified: 2017-01

Locations

CZ (3); ES (2); LI (1); RO (1); PL (6); US (5); DK (3); BR (5); HK (1); AR (1)