Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis

NCT01657162 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: BA058-05-005ACTIVExtend Trial2012-002216-10
• Study Type: interventional
• Target: 1,139
• Locations: 10 countries
• Sites: 25

Brief Summary

The purpose of this study is to provide 24 months of standard of care data on participants previously enrolled in Study BA058-05-003 (NCT02653417).

Conditions

Postmenopausal Osteoporosis

Keywords

BA058; Abaloparatide-SC; abaloparatide; ACTIVExtend; osteoporosis; fracture; bone loss

Outcome Measures

Primary Outcomes (1)

• Number of Participants With ≥1 New Vertebral Fracture Since Study BA058-05-003 Baseline

  Vertebral fractures were determined clinically and via protocol directed radiograph evaluation. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.

  Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Secondary Outcomes (10)

• Number of Participants With a Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined)

  Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

• Percent Change From Study BA058-05-003 Baseline in Total Hip BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

  Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

• Percent Change From Study BA058-05-003 Baseline in Femoral Neck BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

  Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

• Percent Change From Study BA058-05-003 Baseline in Lumbar Spine BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

  Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

• Kaplan-Meier Estimated Event Rate of the First Incident of Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined)

  Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Study Arms (1)

Alendronate

EXPERIMENTAL

Participants received 70 milligrams (mg) of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide 80 micrograms (mcg) SC or abaloparatide-matching placebo daily for 18 months.

Drug: Alendronate

Interventions

Alendronate DRUG

Alendronate is a bisphosphonate drug that prevents bone resorption by osteoclast and is used for the treatment of osteoporosis.

Also known as: Fosamax, Alendronate sodium

Alendronate

Eligibility Criteria

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

You may qualify if:

• The participant was enrolled, randomized to either the abaloparatide-SC (BA058) or placebo arm, and successfully completed Study BA058-05-003 (NCT02653417).
• The participant was no more than 40 days from End-of-Treatment (Month 18) in Study BA058-05-003 (NCT02653417).

You may not qualify if:

• Participants who were withdrawn from Study BA058-05-003 (NCT02653417) for any reason.
• Participants who experienced a treatment-related serious adverse event (SAE) during Study BA058-05-003 (NCT02653417).

Sponsors & Collaborators

• Radius Health, Inc.: lead

Study Sites (25)

Unknown Facility

Lakewood, Colorado, United States

Location

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Hialeah, Florida, 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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Brno-Vinohrady, Czechia

Location

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Pardubice, Czechia

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Aalborg, Denmark

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Ballerup Municipality, Denmark

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Vejle, Denmark

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Tallinn, Estonia

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Tartu, Estonia

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Hong Kong, Hong Kong

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Vilnius, Lithuania

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Bialystok, Poland

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Kielce, Poland

Location

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Lodz, Poland

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Warsaw, Poland

Location

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Zgierz, Poland

Location

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Bucharest, Romania

Location

Related Publications (8)

• Cosman F, Miller PD, Williams GC, Hattersley G, Hu MY, Valter I, Fitzpatrick LA, Riis BJ, Christiansen C, Bilezikian JP, Black D. Eighteen Months of Treatment With Subcutaneous Abaloparatide Followed by 6 Months of Treatment With Alendronate in Postmenopausal Women With Osteoporosis: Results of the ACTIVExtend Trial. Mayo Clin Proc. 2017 Feb;92(2):200-210. doi: 10.1016/j.mayocp.2016.10.009.

  PMID: 28160873 RESULT

• Bone HG, Cosman F, Miller PD, Williams GC, Hattersley G, Hu MY, Fitzpatrick LA, Mitlak B, Papapoulos S, Rizzoli R, Dore RK, Bilezikian JP, Saag KG. ACTIVExtend: 24 Months of Alendronate After 18 Months of Abaloparatide or Placebo for Postmenopausal Osteoporosis. J Clin Endocrinol Metab. 2018 Aug 1;103(8):2949-2957. doi: 10.1210/jc.2018-00163.

  PMID: 29800372 RESULT

• 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

• Watts NB, Dore RK, Baim S, Mitlak B, Hattersley G, Wang Y, Rozental TD, LeBoff MS. Forearm bone mineral density and fracture incidence in postmenopausal women with osteoporosis: results from the ACTIVExtend phase 3 trial. Osteoporos Int. 2021 Jan;32(1):55-61. doi: 10.1007/s00198-020-05555-1. Epub 2020 Sep 15.

  PMID: 32935170 DERIVED

• Greenspan SL, Fitzpatrick LA, Mitlak B, Wang Y, Harvey NC, Deal C, Cosman F, McClung M. Abaloparatide followed by alendronate in women >/=80 years with osteoporosis: post hoc analysis of ACTIVExtend. Menopause. 2020 Oct;27(10):1137-1142. doi: 10.1097/GME.0000000000001593.

  PMID: 32665529 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

• 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

MeSH Terms

Conditions

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

Interventions

Alendronate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Results Point of Contact

• Title: Radius Head of Clinical Operations
• Organization: Radius Health, Inc.

(617) 551-4700

Study Officials

• Bruce Mitlak

  Radius Health, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: Even though this is an open-label study, participants and Investigators who will be participating in this study (BA058-05-005) will remain blinded to the prior treatment assignment in Study BA058-05-003 (NCT02653417) until all participants completed the first 6 months of BA058-05-005 for prespecified data analysis. Complete data analysis for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 6, 2012
• Study Start: November 20, 2012
• Primary Completion: October 3, 2016
• Study Completion: October 3, 2016
• Last Updated: December 11, 2020
• Results First Posted: December 11, 2020

Record last verified: 2020-11

Locations

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