ACTIVExtend: 24 Months of Alendronate After 18 Months of Abaloparatide or Placebo for Postmenopausal Osteoporosis.

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

The Journal of clinical endocrinology and metabolism1 Aug 2018Cited by 152 (Europe PMC)

PMID29800372PMCIDPMC6097601DOI10.1210/jc.2018-00163PepBankPUB-29800372

Download PDF PubMedAsk about this study

Jump to 6 results

Summary

PurposeIn women with postmenopausal osteoporosis, we investigated the effects of 24 months of treatment with alendronate (ALN) following 18 months of treatment with abaloparatide (ABL) or placebo (PBO).MethodsWomen who completed ABL or PBO treatment in ACTIVE were eligible to receive up to 24 months of ALN. We evaluated the incidence of vertebral and nonvertebral fractures and changes in bone mineral density (BMD) during the entire 43-month period from ACTIVE baseline to the end of ACTIVExtend and for the 24-month extension only.ResultsFive hundred fifty-eight women from ACTIVE's ABL group and 581 from its PBO group (92% of ABL and PBO completers) were enrolled. During the full 43-month treatment period, 0.9% of evaluable women in the ABL/ALN group experienced a new radiographic vertebral fracture vs 5.6% of women in the PBO/ALN group, an 84% relative risk reduction (RRR, P < 0.001). Kaplan-Meier incidence rates for other reported fracture types were significantly lower for ABL/ALN vs PBO/ALN (all P < 0.05). Gains in BMD achieved during ACTIVE were further increased during ACTIVExtend. For ACTIVExtend only, RRR for vertebral fractures was 87% with ABL/ALN vs PBO/ALN (P = 0.001). Adverse events were similar between groups. A supplemental analysis for regulatory authorities found no hip fractures in the ABL/ALN group vs five in the PBO/ALN group.ConclusionsEighteen months of ABL followed by 24 months of ALN reduced the risk of vertebral, nonvertebral, clinical, and major osteoporotic fractures and increased BMD. Sequential ABL followed by ALN appears to be an effective treatment option for postmenopausal women at risk for osteoporosis-related fractures.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In postmenopausal women, abaloparatide/alendronate reduced new radiographic vertebral fracture incidence versus placebo/alendronate over the full study.
In plain wordsIn postmenopausal women, abaloparatide then alendronate reduced new vertebral fractures compared with placebo then alendronate.
Peptide
Abaloparatide (Tymlos)
Outcome
DecreaseNew radiographic vertebral fracture over full follow-up
Study
n: not reported in source
Comparator
Placebo followed by alendronate
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · 18 monthsAs given in this study (human).
Measurements
Vertebral fracture incidence
0.9%
ABL/ALN
Vertebral fracture incidence
5.6%
PBO/ALN
Relative risk reduction
84%
full 43-month period
Source sentences
Summary
During the full 43-month treatment period, 0.9% of evaluable women in the ABL/ALN group experienced a new radiographic vertebral fracture vs 5.6% of women in the PBO/ALN group, an 84% relative risk reduction (RRR, P < 0.001).
3 context sentences(design, population, supporting numbers)
Summary · context
In women with postmenopausal osteoporosis, we investigated the effects of 24 months of treatment with alendronate (ALN) following 18 months of treatment with abaloparatide (ABL) or placebo (PBO).
Summary · context
Women who completed ABL or PBO treatment in ACTIVE were eligible to receive up to 24 months of ALN.
Summary · context
We evaluated the incidence of vertebral and nonvertebral fractures and changes in bone mineral density (BMD) during the entire 43-month period from ACTIVE baseline to the end of ACTIVExtend and for the 24-month extension only.
Show in the study text Report a problemFND-2980037201
02HumanRandomized controlled trialEfficacy outcome
In postmenopausal women, incidence rates for other reported fracture types were lower with abaloparatide/alendronate than placebo/alendronate.
In plain wordsIn postmenopausal women, other reported fractures occurred less often with abaloparatide then alendronate than placebo then alendronate.
Peptide
Abaloparatide (Tymlos)
Outcome
DecreaseOther reported fracture types
Study
n: not reported in source
Comparator
Placebo followed by alendronate
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · 18 monthsAs given in this study (human).
Source sentences
Summary
Kaplan-Meier incidence rates for other reported fracture types were significantly lower for ABL/ALN vs PBO/ALN (all P < 0.05).
3 context sentences(design, population, supporting numbers)
Summary · context
In women with postmenopausal osteoporosis, we investigated the effects of 24 months of treatment with alendronate (ALN) following 18 months of treatment with abaloparatide (ABL) or placebo (PBO).
Summary · context
Women who completed ABL or PBO treatment in ACTIVE were eligible to receive up to 24 months of ALN.
Summary · context
We evaluated the incidence of vertebral and nonvertebral fractures and changes in bone mineral density (BMD) during the entire 43-month period from ACTIVE baseline to the end of ACTIVExtend and for the 24-month extension only.
Show in the study text Report a problemFND-2980037202
03HumanRandomized controlled trialEfficacy outcome
In postmenopausal women, abaloparatide/alendronate reduced vertebral fracture risk versus placebo/alendronate during the extension.
In plain wordsIn postmenopausal women, vertebral fracture risk during extension was lower after abaloparatide than placebo, with both groups receiving alendronate.
Peptide
Abaloparatide (Tymlos)
Outcome
DecreaseVertebral fracture risk during extension
Study
n: not reported in source
Comparator
Placebo followed by alendronate
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · 18 monthsAs given in this study (human).
Measurements
Relative risk reduction
87%
ACTIVExtend only
Source sentences
Summary
For ACTIVExtend only, RRR for vertebral fractures was 87% with ABL/ALN vs PBO/ALN (P = 0.001).
3 context sentences(design, population, supporting numbers)
Summary · context
In women with postmenopausal osteoporosis, we investigated the effects of 24 months of treatment with alendronate (ALN) following 18 months of treatment with abaloparatide (ABL) or placebo (PBO).
Summary · context
Women who completed ABL or PBO treatment in ACTIVE were eligible to receive up to 24 months of ALN.
Summary · context
We evaluated the incidence of vertebral and nonvertebral fractures and changes in bone mineral density (BMD) during the entire 43-month period from ACTIVE baseline to the end of ACTIVExtend and for the 24-month extension only.
Show in the study text Report a problemFND-2980037204
04HumanRandomized controlled trialSafety outcome
In postmenopausal women, adverse events were similar with abaloparatide/alendronate and placebo/alendronate.
In plain wordsIn postmenopausal women, adverse events were similar with abaloparatide then alendronate and placebo then alendronate.
Peptide
Abaloparatide (Tymlos)
Outcome
No significant changeAdverse events
Study
n: not reported in source
Comparator
Placebo followed by alendronate
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · 18 monthsAs given in this study (human).
Source sentences
Summary
Adverse events were similar between groups.
3 context sentences(design, population, supporting numbers)
Summary · context
In women with postmenopausal osteoporosis, we investigated the effects of 24 months of treatment with alendronate (ALN) following 18 months of treatment with abaloparatide (ABL) or placebo (PBO).
Summary · context
Women who completed ABL or PBO treatment in ACTIVE were eligible to receive up to 24 months of ALN.
Summary · context
We evaluated the incidence of vertebral and nonvertebral fractures and changes in bone mineral density (BMD) during the entire 43-month period from ACTIVE baseline to the end of ACTIVExtend and for the 24-month extension only.
Show in the study text Report a problemFND-2980037205
05HumanRandomized controlled trialEfficacy outcome
In postmenopausal women, the supplemental analysis found no hip fractures with abaloparatide/alendronate versus five with placebo/alendronate.
In plain wordsIn postmenopausal women, no hip fractures occurred with abaloparatide then alendronate, compared with five after placebo then alendronate.
Peptide
Abaloparatide (Tymlos)
Outcome
DecreaseHip fractures in supplemental analysis
Study
n: not reported in source
Comparator
Placebo followed by alendronate
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · 18 monthsAs given in this study (human).
Measurements
Hip fractures
5 fractures
PBO/ALN group
Source sentences
Summary
A supplemental analysis for regulatory authorities found no hip fractures in the ABL/ALN group vs five in the PBO/ALN group.
3 context sentences(design, population, supporting numbers)
Summary · context
In women with postmenopausal osteoporosis, we investigated the effects of 24 months of treatment with alendronate (ALN) following 18 months of treatment with abaloparatide (ABL) or placebo (PBO).
Summary · context
Women who completed ABL or PBO treatment in ACTIVE were eligible to receive up to 24 months of ALN.
Summary · context
We evaluated the incidence of vertebral and nonvertebral fractures and changes in bone mineral density (BMD) during the entire 43-month period from ACTIVE baseline to the end of ACTIVExtend and for the 24-month extension only.
Show in the study text Report a problemFND-2980037206

Studies that did not test the peptide alone1

In this study, Abaloparatide (Tymlos) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Abaloparatide (Tymlos).

06HumanNot a test of Abaloparatide (Tymlos) aloneRandomized controlled trialEfficacy outcome
In postmenopausal women, BMD gains achieved during ACTIVE increased further during the alendronate extension.
In plain wordsIn postmenopausal women, bone density gains increased further during alendronate treatment after abaloparatide or placebo.
Peptide
Abaloparatide (Tymlos)
Outcome
IncreaseBMD gains during extension
Study
n: not reported in source
Outcome group
Bone and joint · Musculoskeletal
Source sentences
Summary
Gains in BMD achieved during ACTIVE were further increased during ACTIVExtend.
3 context sentences(design, population, supporting numbers)
Summary · context
In women with postmenopausal osteoporosis, we investigated the effects of 24 months of treatment with alendronate (ALN) following 18 months of treatment with abaloparatide (ABL) or placebo (PBO).
Summary · context
Women who completed ABL or PBO treatment in ACTIVE were eligible to receive up to 24 months of ALN.
Summary · context
We evaluated the incidence of vertebral and nonvertebral fractures and changes in bone mineral density (BMD) during the entire 43-month period from ACTIVE baseline to the end of ACTIVExtend and for the 24-month extension only.
In this study, Abaloparatide (Tymlos) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Abaloparatide (Tymlos).
Show in the study text Report a problemFND-2980037203

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

Registered trials1

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

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

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

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

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

PepBank is a research reference. Talk to a doctor before you use any peptide.