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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women

Short name ACTIVE

NCTNCT01343004 (opens ClinicalTrials.gov in a new tab)Other idBA058-05-003Other idACTIVE Trial
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
2,463 participants (actual)
Sponsor
Radius Health, Inc. · Industry
Design
Randomized · Quadruple masking
Countries
10 countries

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

Start
Apr 2011
Primary completion
Oct 2014
Completion
Oct 2014
First posted
27 Apr 2011 (estimated)
Last update posted
1 Mar 2017
Conditions
Osteoporosis · Postmenopausal Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20112012201320142015
  1. Ph 3

    ACTIVE

    NCT01343004

    Apr 2011 to Oct 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures.

Interventions

  • PlaceboDrug
  • BA058 80 mcgDrug
  • teriparatideDrug

Arms3

  • Placebo comparator

    Placebo

    Placebo identical in appearance to BA058 study drug

  • Experimental

    BA058 80 mcg (abaloparatide)

  • Active comparator

    teriparatide

    Blinded until after randomization, then open-label

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With New Vertebral Fractures at 18 Months

    Time frame · 18 months

Secondary outcomes(5)

  1. Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months

    Time frame · Basline and 18 months

  2. Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18

    Time frame · Baseline and 18 months

  3. Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18

    Time frame · Baseline and 18 months

  4. Number of Participants With Non-vertebral Fractures at 18 Months

    Time frame · 18 months

  5. Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months

    Time frame · 18 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 18 months

Number of Participants With New Vertebral Fractures at 18 Months

GroupValue (participants)
Placebo30
BA058 80 mcg (Abaloparatide)4
Teriparatide6
Secondary and other outcome results(5)
Secondary outcomeMean· Basline and 18 months

Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months

GroupValue (percent change from baseline)Spread
Placebo0.483.82
BA058 80 mcg (Abaloparatide)9.207.54
Teriparatide9.126.28
Secondary outcomeMean· Baseline and 18 months

Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18

GroupValue (percent change)Spread
Placebo-0.082.77
BA058 80 mcg (Abaloparatide)3.443.51
Teriparatide2.813.33
Secondary outcomeMean· Baseline and 18 months

Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18

GroupValue (percent change)Spread
Placebo-0.443.57
BA058 80 mcg (Abaloparatide)2.904.21
Teriparatide2.263.57
Secondary outcomeNumber· 18 months

Number of Participants With Non-vertebral Fractures at 18 Months

GroupValue (Participants)
Placebo33
BA058 80 mcg (Abaloparatide)18
Teriparatide24
Secondary outcomeNumber· 18 months

Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months

GroupValue (Hypercalcemic events)
Placebo5
BA058 80 mcg (Abaloparatide)15
Teriparatide34

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboPlacebo identical in appearance to BA058 study drug Placebo: Placebo 0 mcg subcutaneous daily–90 / 820447 / 820
BA058 80 mcg (Abaloparatide)BA058 80 mcg: BA058 80 mcg subcutaneous daily–80 / 822492 / 822
TeriparatideBlinded until after randomization, then open-label teriparatide: teriparatide 20 mcg subcutaneous daily–82 / 818456 / 818

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies11

Studies that cite this trial.

Studies with results

7 studies on this page

PubMed tag: none · 2025

16 results

Effect of abaloparatide on fracture incidence and bone mineral density in postmenopausal women with osteoporosis at highest risk for fracture.

DeSapri et al. 2025Menopause (New York, N.Y.)cited by 4

PMID 39999474PMC12024850DOI 10.1097/gme.0000000000002516PUB-39999474

Free to read · publisher termsCC BY-NC-ND16 results
Read at sourceSee results (16)

PubMed tag: none · 2025

7 results

Abaloparatide effects on BMD in acetabular regions corresponding to DeLee and Charnley zones in women with postmenopausal osteoporosis.

Sheth et al. 2025Bone reports

PMID 40786602PMC12332864DOI 10.1016/j.bonr.2025.101858PUB-40786602

CC BY7 results
Download PDFSee results (7)

Indexing hint: Randomized controlled trial · 2023

6 results

Effect of Abaloparatide on Bone Microarchitecture Assessed by Trabecular Bone Score in Women With Osteoporosis: Post Hoc Analysis of ACTIVE and ACTIVExtend.

Cosman et al. 2023Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 5

PMID 36588166DOI 10.1002/jbmr.4764PUB-36588166

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: Randomized controlled trial · 2020

10 results

Cardiovascular Safety of Abaloparatide in Postmenopausal Women With Osteoporosis: Analysis From the ACTIVE Phase 3 Trial.

Cosman et al. 2020The Journal of clinical endocrinology and metabolismcited by 33

PMID 32658264PMC7500469DOI 10.1210/clinem/dgaa450PUB-32658264

CC BY10 results
Download PDFSee results (10)

Indexing hint: Randomized controlled trial · 2019

8 results

Fracture and Bone Mineral Density Response by Baseline Risk in Patients Treated With Abaloparatide Followed by Alendronate: Results From the Phase 3 ACTIVExtend Trial.

Leder et al. 2019Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 14

PMID 31411768PMC6916366DOI 10.1002/jbmr.3848PUB-31411768

CC BY8 results
Download PDFSee results (8)

Indexing hint: Randomized controlled trial · 2017

3 results

Effects of Abaloparatide-SC on Fractures and Bone Mineral Density in Subgroups of Postmenopausal Women With Osteoporosis and Varying Baseline Risk Factors.

Cosman et al. 2017Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 63

PMID 27612281DOI 10.1002/jbmr.2991PUB-27612281

Rights unknown3 results
Source linkSee results (3)

Indexing hint: Randomized controlled trial · 2017

10 results

Effects of abaloparatide-SC (BA058) on bone histology and histomorphometry: The ACTIVE phase 3 trial.

Moreira et al. 2017Bonecited by 57

PMID 27826127DOI 10.1016/j.bone.2016.11.004PUB-27826127

Full text at the publisher10 results
Publisher pageSee results (10)

More studies

4 studies on this page

Indexing hint: Meta-analysis (pooled) · 2021

Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D.

Hara et al. 2021The Cochrane database of systematic reviewscited by 18

PMID 34231877PMC8262129DOI 10.1002/14651858.cd013424.pub2PUB-34231877

Rights unknown
Source link

Indexing hint: Randomized controlled trial · 2020

Corrected

Effect of Abaloparatide vs Alendronate on Fracture Risk Reduction in Postmenopausal Women With Osteoporosis.

Leder et al. 2020The Journal of clinical endocrinology and metabolismcited by 37

PMID 31674644PMC7112966DOI 10.1210/clinem/dgz162PUB-31674644

CC BY
Download PDFRead the notice

Indexing hint: Randomized controlled trial · 2020

Corrected

Effect of Abaloparatide on Bone Mineral Density and Fracture Incidence in a Subset of Younger Postmenopausal Women with Osteoporosis at High Risk for Fracture.

Saag et al. 2020Clinical therapeuticscited by 11

PMID 32513495DOI 10.1016/j.clinthera.2020.04.012PUB-32513495

Free to read · publisher termsCC BY-NC-ND
Read at sourceRead the notice

Indexing hint: Randomized controlled trial · 2016

Corrected

Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial.

Miller et al. 2016JAMAcited by 632

PMID 27533157DOI 10.1001/jama.2016.11136PUB-27533157

Full text at the publisher
Publisher pageRead the notice

Eligibility

Who could join, as posted.

Sex
Female
Age
from 50 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Healthy ambulatory postmenopausal (≥ 5 years) women from 50 to 85 years of age (inclusive) with a diagnosis of osteoporosis * The women are to have a bone mineral density (BMD) T score ≤ -2.5 and \> -5.0 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures, or history of low trauma forearm, humerus, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years. Postmenopausal women older than 65 who meet the above fracture criteria but have a T score ≤ -2.0 and \> -5.0 may be enrolled. Women older than 65 who do not meet the fracture criteria may also be enrolled if their T score is ≤ -3.0 and \> -5.0 * Normal physical exam, vital signs, electrocardiogram (ECG) and medical history * Laboratory tests within the normal range including serum calcium, PTH(1-84), serum phosphorus and alkaline phosphatase Exclusion Criteria: * History of more than 4 mild or moderate spine fractures or any severe fracture * Abnormality of the spine or hip that would prohibit assessment of bone mineral density (BMD) * Unexplained elevation of serum alkaline phosphatase, history of bone disorders (such as Paget's disease) or a diagnosis of cancer within the last 5 years (with the exception of basal cell or squamous cancer of the skin) * History of thyroid, parathyroid, or adrenal disorders, or malabsorptive syndromes or any chronic or recurrent diseases or disturbances that would interfere with the interpretation of study data or compromise the safety of the patient * Prior treatment with parathyroid hormone (PTH) or parathyroid hormone-related peptid (PTHrP) * Prior treatment with bisphosphonates, fluoride, or strontium within the past five years or treatment with androgens, anabolic steroids, corticosteroids or selective estrogen receptor modulators within the past 12 months (except hormone replacement therapy) * Prior treatment with an investigational drug within the past 12 months * History of nephrolithiasis or urolithiasis within the past five years, or history of osteosarcoma at any time

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