Clinical trial NCT01657162: Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis
Official title: An Extension Study to Evaluate 24 Months of Standard-of-Care Osteoporosis Management Following Completion of 18 Months of BA058 or Placebo Treatment in Protocol BA058-05-003
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Osteoporosis
Keywords: BA058
Abaloparatide-SC
abaloparatide
ACTIVExtend
osteoporosis
fracture
bone loss
Lead sponsor: Radius Health, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-06
Enrollment: 1139
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Detailed description: 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.

Eligibility criteria: 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 Participants who were withdrawn from Study BA058-05-003 (NCT02653417) for any reason.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).

Primary outcomes:
measure: Number of Participants With ≥1 New Vertebral Fracture Since Study BA058-05-003 Baseline
timeFrame: Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)
Secondary outcomes:
measure: Number of Participants With a Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined)
timeFrame: Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)
measure: 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)
timeFrame: Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)
measure: 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)
timeFrame: Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)
measure: 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)
timeFrame: Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)
measure: 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)
timeFrame: Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only)
timeFrame: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
measure: Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only)
timeFrame: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
measure: Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only)
timeFrame: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
measure: Number of Participants With a Clinically Notable Coagulation Laboratory Value (Data From Study BA058-05-005 Only)
timeFrame: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
measure: Number of Participants With a Clinically Notable Urine Laboratory Value (Data From Study BA058-05-005 Only)
timeFrame: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Other outcomes:
Locations:
city: Lakewood
country: United States
state: Colorado
city: Hialeah
country: United States
state: Florida
city: Bethesda
country: United States
state: Maryland
city: Buenos Aires
country: Argentina
city: Brasilia
country: Brazil
city: Curitiba
country: Brazil
city: Rio de Janeiro
country: Brazil
city: São Paulo
country: Brazil
city: Vitoria
country: Brazil
city: Brno
country: Czechia
city: Pardubice
country: Czechia
city: Vinohrady
country: Czechia
city: Aalborg
country: Denmark
city: Ballerup
country: Denmark
city: Vejle
country: Denmark
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Hong Kong
country: Hong Kong
city: Vilnius
country: Lithuania
city: Bialystok
country: Poland
city: Kielce
country: Poland
city: Lodz
country: Poland
city: Warsaw
country: Poland
city: Zgierz
country: Poland
city: Bucharest
country: Romania
Study officials:
affiliation: Radius Health, Inc.
name: Bruce Mitlak
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.