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Abaloparatide followed by alendronate in women ≥80 years with osteoporosis: post hoc analysis of ACTIVExtend

Abaloparatide followed by alendronate in women ≥80 years with osteoporosis: post hoc analysis of ACTIVExtend
Abaloparatide followed by alendronate in women ≥80 years with osteoporosis: post hoc analysis of ACTIVExtend
Objective: Fracture risk increases with age, but few studies focus on persons ≥80 years. In the ACTIVE trial, treatment with abaloparatide for 18 months reduced osteoporotic fracture risk and increased bone mineral density. These effects were maintained with 24 months alendronate treatment in ACTIVExtend. We postulated that similar improvements in bone mineral density and safety would be demonstrated in women ≥80 years. Methods: Post hoc analyses of bone mineral density and fracture incidence in women with osteoporosis at high risk of fracture ≥80 years from ACTIVExtend. Results: In total, 56 women aged ≥80 years at ACTIVE baseline entered the ACTIVExtend study; 46 of these completed the study. Mean age was 83.3 years; other baseline characteristics were similar. At the end of ACTIVE, bone mineral density increased at all sites for abaloparatide versus placebo. Bone mineral density increased in parallel in both groups during alendronate therapy (19 to 43 months) in ACTIVExtend. At month 43, mean percent change in bone mineral density from baseline was 17.2% abaloparatide/alendronate versus 8.6% placebo/alendronate (P < 0.0001) at the lumbar spine, 5.3% abaloparatide/alendronate versus 3.0% placebo/alendronate (P = 0.024) at the total hip, and 4.6% abaloparatide/alendronate versus 3.1% placebo/alendronate (P = 0.044) at the femoral neck. Fracture incidence was low and did not differ significantly between groups. Sequential treatment with abaloparatide followed by alendronate was well tolerated; the proportion of participants reporting adverse events was similar between groups. Conclusions: Sequential treatment with abaloparatide followed by alendronate (43 months follow-up) in this small subgroup of ACTIVExtend participants suggests abaloparatide is well tolerated and effective in women aged ≥80 years.
1072-3714
1137-1142
Greenspan, Susan L.
69b09b9d-bff3-428b-b0cd-e746e1095159
Fitzpatrick, Lorraine A
9afabbea-efad-4e03-9e5e-364a07db31dd
Mitlak, Bruce H.
87a42948-037b-4fd6-a39b-40d48cfa318c
Wang, Yamei
cd276aac-3032-45ad-b598-1e692aca723c
Harvey, Nicholas
ce487fb4-d360-4aac-9d17-9466d6cba145
Deal, Chad
afd53dfe-8385-4440-bcb7-381a417840d4
Cosman, Felicia
5247c9a0-d4f0-407b-b678-d290f0885562
McClung, Michael R.
906c38b0-c914-4ff3-a31e-74bd6d895c54
Greenspan, Susan L.
69b09b9d-bff3-428b-b0cd-e746e1095159
Fitzpatrick, Lorraine A
9afabbea-efad-4e03-9e5e-364a07db31dd
Mitlak, Bruce H.
87a42948-037b-4fd6-a39b-40d48cfa318c
Wang, Yamei
cd276aac-3032-45ad-b598-1e692aca723c
Harvey, Nicholas
ce487fb4-d360-4aac-9d17-9466d6cba145
Deal, Chad
afd53dfe-8385-4440-bcb7-381a417840d4
Cosman, Felicia
5247c9a0-d4f0-407b-b678-d290f0885562
McClung, Michael R.
906c38b0-c914-4ff3-a31e-74bd6d895c54

Greenspan, Susan L., Fitzpatrick, Lorraine A, Mitlak, Bruce H., Wang, Yamei, Harvey, Nicholas, Deal, Chad, Cosman, Felicia and McClung, Michael R. (2020) Abaloparatide followed by alendronate in women ≥80 years with osteoporosis: post hoc analysis of ACTIVExtend. Menopause, 27 (10), 1137-1142. (doi:10.1097/GME.0000000000001593). (In Press)

Record type: Article

Abstract

Objective: Fracture risk increases with age, but few studies focus on persons ≥80 years. In the ACTIVE trial, treatment with abaloparatide for 18 months reduced osteoporotic fracture risk and increased bone mineral density. These effects were maintained with 24 months alendronate treatment in ACTIVExtend. We postulated that similar improvements in bone mineral density and safety would be demonstrated in women ≥80 years. Methods: Post hoc analyses of bone mineral density and fracture incidence in women with osteoporosis at high risk of fracture ≥80 years from ACTIVExtend. Results: In total, 56 women aged ≥80 years at ACTIVE baseline entered the ACTIVExtend study; 46 of these completed the study. Mean age was 83.3 years; other baseline characteristics were similar. At the end of ACTIVE, bone mineral density increased at all sites for abaloparatide versus placebo. Bone mineral density increased in parallel in both groups during alendronate therapy (19 to 43 months) in ACTIVExtend. At month 43, mean percent change in bone mineral density from baseline was 17.2% abaloparatide/alendronate versus 8.6% placebo/alendronate (P < 0.0001) at the lumbar spine, 5.3% abaloparatide/alendronate versus 3.0% placebo/alendronate (P = 0.024) at the total hip, and 4.6% abaloparatide/alendronate versus 3.1% placebo/alendronate (P = 0.044) at the femoral neck. Fracture incidence was low and did not differ significantly between groups. Sequential treatment with abaloparatide followed by alendronate was well tolerated; the proportion of participants reporting adverse events was similar between groups. Conclusions: Sequential treatment with abaloparatide followed by alendronate (43 months follow-up) in this small subgroup of ACTIVExtend participants suggests abaloparatide is well tolerated and effective in women aged ≥80 years.

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Accepted/In Press date: 6 April 2020

Identifiers

Local EPrints ID: 442771
URI: http://eprints.soton.ac.uk/id/eprint/442771
ISSN: 1072-3714
PURE UUID: c68c292e-a396-4858-a60e-e47a19807f2f
ORCID for Nicholas Harvey: ORCID iD orcid.org/0000-0002-8194-2512

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Date deposited: 27 Jul 2020 16:30
Last modified: 26 Nov 2021 02:48

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Contributors

Author: Susan L. Greenspan
Author: Lorraine A Fitzpatrick
Author: Bruce H. Mitlak
Author: Yamei Wang
Author: Nicholas Harvey ORCID iD
Author: Chad Deal
Author: Felicia Cosman
Author: Michael R. McClung

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