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.

Cosman F, Miller PD, Williams GC, Hattersley G, Hu MY, Valter I, Fitzpatrick LA, Riis BJ, Christiansen C, Bilezikian JP, Black D

Mayo Clinic proceedings1 Feb 2017Cited by 96 (Europe PMC)

PMID28160873DOI10.1016/j.mayocp.2016.10.009PepBankPUB-28160873

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In postmenopausal women with osteoporosis, abaloparatide followed by alendronate reduced vertebral fractures versus placebo followed by alendronate.
In plain wordsIn women with osteoporosis, abaloparatide then alendronate reduced vertebral fractures versus placebo then alendronate.
Peptide
Abaloparatide (Tymlos)
Outcome
DecreaseNew morphometric vertebral fractures
Study
n: not reported in source
Comparator
placebo followed by alendronate
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · subcutaneous · 18 monthsAs given in this study (human).
Measurements
Fracture incidence
0.55%
ABL-SC/ALN
Fracture incidence
4.4%
PBO/ALN
Relative risk
0.13 ratio
ABL-SC/ALN versus PBO/ALN
Relative risk reduction
87%
ABL-SC/ALN versus PBO/ALN
Source sentences
Summary
Findings indicated percentages of patients with new morphometric vertebral fractures: PBO/ALN, 4.4% vs ABL-SC/ALN, 0.55%; relative risk reduction, 87% (relative risk, 0.13; 95% CI, 0.04-0.41; P<.001).
2 context sentences(design, population, supporting numbers)
Summary · context
To assess the efficacy and safety of 18 months of subcutaneous abaloparatide (ABL-SC) or placebo (PBO) followed by 6 months of alendronate (ALN) (preplanned interim analysis).
Summary · context
ACTIVExtend, an extension of ACTIVE, enrolled patients who completed 18 months of ABL-SC or PBO in ACTIVE to receive up to 24 additional months of open-label ALN; there was 1 month between the studies to re-consent patients.
Report a problemFND-2816087301
02HumanRandomized controlled trialEfficacy outcome
In postmenopausal women with osteoporosis, abaloparatide followed by alendronate reduced nonvertebral fractures versus placebo followed by alendronate.
In plain wordsIn women with osteoporosis, abaloparatide then alendronate reduced nonvertebral fractures versus placebo then alendronate.
Peptide
Abaloparatide (Tymlos)
Outcome
DecreaseNonvertebral fractures
Study
n: not reported in source
Comparator
placebo followed by alendronate
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · subcutaneous · 18 monthsAs given in this study (human).
Measurements
Fracture rate
2.7%
ABL-SC/ALN
Fracture rate
5.6%
PBO/ALN
Hazard ratio
0.48 ratio
ABL-SC/ALN versus PBO/ALN
Risk reduction
52%
ABL-SC/ALN versus PBO/ALN
Source sentences
Summary
Kaplan-Meier estimated rates of nonvertebral fractures were PBO/ALN, 5.6% vs ABL-SC/ALN, 2.7%; risk reduction, 52% (hazard ratio [HR], 0.48; 95% CI, 0.26-0.89; log-rank P=.02).
2 context sentences(design, population, supporting numbers)
Summary · context
To assess the efficacy and safety of 18 months of subcutaneous abaloparatide (ABL-SC) or placebo (PBO) followed by 6 months of alendronate (ALN) (preplanned interim analysis).
Summary · context
ACTIVExtend, an extension of ACTIVE, enrolled patients who completed 18 months of ABL-SC or PBO in ACTIVE to receive up to 24 additional months of open-label ALN; there was 1 month between the studies to re-consent patients.
Report a problemFND-2816087302
03HumanRandomized controlled trialEfficacy outcome
In postmenopausal women with osteoporosis, abaloparatide followed by alendronate reduced major osteoporotic fractures versus placebo followed by alendronate.
In plain wordsIn women with osteoporosis, abaloparatide then alendronate reduced major osteoporotic fractures versus placebo then alendronate.
Peptide
Abaloparatide (Tymlos)
Outcome
DecreaseMajor osteoporotic fractures
Study
n: not reported in source
Comparator
placebo followed by alendronate
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · subcutaneous · 18 monthsAs given in this study (human).
Measurements
Risk reduction
58%
ABL-SC/ALN versus PBO/ALN
Hazard ratio
0.42 ratio
ABL-SC/ALN versus PBO/ALN
Source sentences
Summary
There was also a 58% risk reduction of major osteoporotic fractures (HR, 0.42; 95% CI, 0.21-0.85; log-rank P=.01) and a 45% risk reduction of clinical fractures (HR, 0.55; 95% CI, 0.33-0.92; log-rank P=.02) in the ABL-SC/ALN group vs the PBO/ALN group.
2 context sentences(design, population, supporting numbers)
Summary · context
To assess the efficacy and safety of 18 months of subcutaneous abaloparatide (ABL-SC) or placebo (PBO) followed by 6 months of alendronate (ALN) (preplanned interim analysis).
Summary · context
ACTIVExtend, an extension of ACTIVE, enrolled patients who completed 18 months of ABL-SC or PBO in ACTIVE to receive up to 24 additional months of open-label ALN; there was 1 month between the studies to re-consent patients.
Report a problemFND-2816087303
04HumanRandomized controlled trialEfficacy outcome
In postmenopausal women with osteoporosis, abaloparatide followed by alendronate reduced clinical fractures versus placebo followed by alendronate.
In plain wordsIn women with osteoporosis, abaloparatide then alendronate reduced clinical fractures versus placebo then alendronate.
Peptide
Abaloparatide (Tymlos)
Outcome
DecreaseClinical fractures
Study
n: not reported in source
Comparator
placebo followed by alendronate
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · subcutaneous · 18 monthsAs given in this study (human).
Measurements
Risk reduction
45%
ABL-SC/ALN versus PBO/ALN
Hazard ratio
0.55 ratio
ABL-SC/ALN versus PBO/ALN
Source sentences
Summary
There was also a 58% risk reduction of major osteoporotic fractures (HR, 0.42; 95% CI, 0.21-0.85; log-rank P=.01) and a 45% risk reduction of clinical fractures (HR, 0.55; 95% CI, 0.33-0.92; log-rank P=.02) in the ABL-SC/ALN group vs the PBO/ALN group.
2 context sentences(design, population, supporting numbers)
Summary · context
To assess the efficacy and safety of 18 months of subcutaneous abaloparatide (ABL-SC) or placebo (PBO) followed by 6 months of alendronate (ALN) (preplanned interim analysis).
Summary · context
ACTIVExtend, an extension of ACTIVE, enrolled patients who completed 18 months of ABL-SC or PBO in ACTIVE to receive up to 24 additional months of open-label ALN; there was 1 month between the studies to re-consent patients.
Report a problemFND-2816087304
05HumanRandomized controlled trialEfficacy outcome
In women with osteoporosis, lumbar spine BMD increased more after abaloparatide then alendronate than placebo then alendronate.
In plain wordsIn women with osteoporosis, spinal bone density increased more after abaloparatide then alendronate than placebo then alendronate.
Peptide
Abaloparatide (Tymlos)
Outcome
IncreaseLumbar spine BMD at 25 months
Study
n: not reported in source
Comparator
placebo followed by alendronate
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · subcutaneous · 18 monthsAs given in this study (human).
Measurements
BMD change
12.8%
ABL-SC/ALN lumbar spine
BMD change
3.5%
PBO/ALN lumbar spine
Source sentences
Summary
At 25 months, bone mineral density percentage change from ACTIVE baseline for ABL-SC/ALN vs PBO/ALN was as follows: lumbar spine, 12.8%; total hip, 5.5%; femoral neck, 4.5% vs 3.5%, 1.4%, 0.5%, respectively (group differences at all sites P<.001).
2 context sentences(design, population, supporting numbers)
Summary · context
To assess the efficacy and safety of 18 months of subcutaneous abaloparatide (ABL-SC) or placebo (PBO) followed by 6 months of alendronate (ALN) (preplanned interim analysis).
Summary · context
ACTIVExtend, an extension of ACTIVE, enrolled patients who completed 18 months of ABL-SC or PBO in ACTIVE to receive up to 24 additional months of open-label ALN; there was 1 month between the studies to re-consent patients.
Report a problemFND-2816087305
06HumanRandomized controlled trialEfficacy outcome
In women with osteoporosis, total hip BMD increased more after abaloparatide then alendronate than placebo then alendronate.
In plain wordsIn women with osteoporosis, hip bone density increased more after abaloparatide then alendronate than placebo then alendronate.
Peptide
Abaloparatide (Tymlos)
Outcome
IncreaseTotal hip BMD at 25 months
Study
n: not reported in source
Comparator
placebo followed by alendronate
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · subcutaneous · 18 monthsAs given in this study (human).
Measurements
BMD change
5.5%
ABL-SC/ALN total hip
BMD change
1.4%
PBO/ALN total hip
Source sentences
Summary
At 25 months, bone mineral density percentage change from ACTIVE baseline for ABL-SC/ALN vs PBO/ALN was as follows: lumbar spine, 12.8%; total hip, 5.5%; femoral neck, 4.5% vs 3.5%, 1.4%, 0.5%, respectively (group differences at all sites P<.001).
2 context sentences(design, population, supporting numbers)
Summary · context
To assess the efficacy and safety of 18 months of subcutaneous abaloparatide (ABL-SC) or placebo (PBO) followed by 6 months of alendronate (ALN) (preplanned interim analysis).
Summary · context
ACTIVExtend, an extension of ACTIVE, enrolled patients who completed 18 months of ABL-SC or PBO in ACTIVE to receive up to 24 additional months of open-label ALN; there was 1 month between the studies to re-consent patients.
Report a problemFND-2816087306
07HumanRandomized controlled trialEfficacy outcome
In women with osteoporosis, femoral neck BMD increased more after abaloparatide then alendronate than placebo then alendronate.
In plain wordsIn women with osteoporosis, femoral neck bone density increased more after abaloparatide then alendronate than placebo then alendronate.
Peptide
Abaloparatide (Tymlos)
Outcome
IncreaseFemoral neck BMD at 25 months
Study
n: not reported in source
Comparator
placebo followed by alendronate
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · subcutaneous · 18 monthsAs given in this study (human).
Measurements
BMD change
4.5%
ABL-SC/ALN femoral neck
BMD change
0.5%
PBO/ALN femoral neck
Source sentences
Summary
At 25 months, bone mineral density percentage change from ACTIVE baseline for ABL-SC/ALN vs PBO/ALN was as follows: lumbar spine, 12.8%; total hip, 5.5%; femoral neck, 4.5% vs 3.5%, 1.4%, 0.5%, respectively (group differences at all sites P<.001).
2 context sentences(design, population, supporting numbers)
Summary · context
To assess the efficacy and safety of 18 months of subcutaneous abaloparatide (ABL-SC) or placebo (PBO) followed by 6 months of alendronate (ALN) (preplanned interim analysis).
Summary · context
ACTIVExtend, an extension of ACTIVE, enrolled patients who completed 18 months of ABL-SC or PBO in ACTIVE to receive up to 24 additional months of open-label ALN; there was 1 month between the studies to re-consent patients.
Report a problemFND-2816087307

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · 2 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT03710889

Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption

Radius Health, Inc.n = 2320 Sept 2018 to 15 Jul 2020

Osteoporosis, Postmenopausal · Osteoporosis · Osteoporosis Vertebral · Osteoporosis Risk · Osteoporosis Fracture · Osteoporosis Localized to Spine · Osteoporosis, Age-Related · Osteoporosis Senile · Osteoporosis of Vertebrae

Trial page ClinicalTrials.govUpdated 15 Oct 2021

CompletedPhase 3Results postedNCT01657162

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

Radius Health, Inc.n = 1,13920 Nov 2012 to 3 Oct 2016

Postmenopausal Osteoporosis

Trial page ClinicalTrials.govUpdated 11 Dec 2020

Version history

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Version 2Current
22 Oct 2026, 02:25 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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