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

NCT ID: NCT01657162

Last Updated: 2020-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-20

Study Completion Date

2016-10-03

Brief Summary

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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).

Detailed Description

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To assess the long-term effect of the anabolic drug, abaloparatide-subcutaneous (SC) versus placebo in the prevention of bone fracture after cessation of treatment. Participants who completed the 18-month Double-Blind BA058-05-003 (ACTIVE) study (NCT02653417), after receiving abaloparatide-SC or placebo, were enrolled in this extension study to receive 70 mg of alendronate (bisphosphonate) weekly for an additional 24 months. Complete details for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.

Conditions

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Postmenopausal Osteoporosis

Keywords

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BA058 Abaloparatide-SC abaloparatide ACTIVExtend osteoporosis fracture bone loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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Alendronate

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.

Group Type EXPERIMENTAL

Alendronate

Intervention Type DRUG

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

Interventions

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Alendronate

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

Intervention Type DRUG

Other Intervention Names

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Fosamax Alendronate sodium

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Radius Health, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruce Mitlak

Role: STUDY_DIRECTOR

Radius Health, Inc.

Locations

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Lakewood, Colorado, United States

Site Status

Hialeah, Florida, United States

Site Status

Bethesda, Maryland, United States

Site Status

Buenos Aires, , Argentina

Site Status

Brasília, , Brazil

Site Status

Curitiba, , Brazil

Site Status

Rio de Janeiro, , Brazil

Site Status

São Paulo, , Brazil

Site Status

Vitória, , Brazil

Site Status

Brno, , Czechia

Site Status

Pardubice, , Czechia

Site Status

Vinohrady, , Czechia

Site Status

Aalborg, , Denmark

Site Status

Ballerup Municipality, , Denmark

Site Status

Vejle, , Denmark

Site Status

Tallinn, , Estonia

Site Status

Tartu, , Estonia

Site Status

Hong Kong, , Hong Kong

Site Status

Vilnius, , Lithuania

Site Status

Bialystok, , Poland

Site Status

Kielce, , Poland

Site Status

Lodz, , Poland

Site Status

Warsaw, , Poland

Site Status

Zgierz, , Poland

Site Status

Bucharest, , Romania

Site Status

Countries

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United States Argentina Brazil Czechia Denmark Estonia Hong Kong Lithuania Poland Romania

References

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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.

Reference Type RESULT
PMID: 28160873 (View on PubMed)

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.

Reference Type RESULT
PMID: 29800372 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36588166 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32935170 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32665529 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32658264 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31674644 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31411768 (View on PubMed)

Other Identifiers

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ACTIVExtend Trial

Identifier Type: OTHER

Identifier Source: secondary_id

2012-002216-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BA058-05-005

Identifier Type: -

Identifier Source: org_study_id