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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis

Overview

Status
Completed
Phase
Phase 2
Enrollment
222 participants (actual)
Sponsor
Radius Health, Inc. · Industry
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Apr 2007
Primary completion
Jun 2009
Completion
Jun 2009
First posted
11 Oct 2007 (estimated)
Last update posted
30 Oct 2017
Conditions
Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2007200820092010
  1. Ph 2

    Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis

    NCT00542425

    Apr 2007 to Jun 2009

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 is effective in building bone in postmenopausal women with osteoporosis.

Interventions

  • teriparatideDrug
  • PlaceboDrug
  • BA058 20 µgDrug
  • BA058 40 µgDrug
  • BA058 80 µgDrug

Arms5

  • Placebo comparator

    Placebo

  • Experimental

    BA058 20 µg

  • Experimental

    BA058 40 µg

  • Experimental

    BA058 80 µg

  • Active comparator

    teriparatide

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change in Marker of Bone Metabolism, PINP

    Time frame · 6 months

    Registry description

    PINP, N-terminal propeptide of type I procollagen, is a marker of anabolic bone growth.

  2. Change in Bone Mineral Density, Total Spine.

    Time frame · 6 months

    Registry description

    Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 24.

Secondary outcomes(3)
  1. Change in Bone Mineral Density, Femoral Neck.

    Time frame · 6 months

    Registry description

    Femoral neck bone mineral density (BMD) was analyzed by DXA at Week 24.

  2. Change in Bone Mineral Density, Total Hip.

    Time frame · 6 months

    Registry description

    Total analyzable hip bone mineral density (BMD) was analyzed by DXA at Week 24.

  3. Change in Bone Mineral Density, Total Spine.

    Time frame · 12 months

    Registry description

    Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 48.

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 outcomeMean· 6 months

Change in Marker of Bone Metabolism, PINP

GroupValue (Percent change from baseline)Spread
Placebo-13.126.47
BA058 20 µg20.061.05
BA058 40 µg90.8116.92
BA058 80 µg97.2123.88
Teriparatide154.3213.07
Primary outcomeMean· 6 months

Change in Bone Mineral Density, Total Spine.

GroupValue (Percent change from baseline)Spread
Placebo1.223.211
BA058 20 µg3.302.068
BA058 40 µg5.214.427
BA058 80 µg6.113.744
Teriparatide5.474.218
Secondary and other outcome results(3)
Secondary outcomeMean· 6 months

Change in Bone Mineral Density, Femoral Neck.

GroupValue (Percent change from baseline)Spread
Placebo0.794.797
BA058 20 µg2.694.022
BA058 40 µg2.204.406
BA058 80 µg3.074.175
Teriparatide1.074.564
Secondary outcomeMean· 6 months

Change in Bone Mineral Density, Total Hip.

GroupValue (Percent change from baseline)Spread
Placebo0.393.053
BA058 20 µg1.432.639
BA058 40 µg1.973.699
BA058 80 µg2.603.488
Teriparatide0.453.925
Secondary outcomeMean· 12 months

Change in Bone Mineral Density, Total Spine.

GroupValue (Percent change from baseline)Spread
Placebo0.743.541
BA058 20 µg5.143.164
BA058 40 µg9.845.313
BA058 80 µg12.943.251
Teriparatide8.636.8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Placebo–1 / 4530 / 45
BA058 20 µg–2 / 4331 / 43
BA058 40 µg–0 / 4332 / 43
BA058 80 µg–2 / 4533 / 45
Teriparatide–0 / 4535 / 45

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2015

7 results

Effects of abaloparatide, a human parathyroid hormone-related peptide analog, on bone mineral density in postmenopausal women with osteoporosis.

Leder et al. 2015The Journal of clinical endocrinology and metabolismcited by 193

PMID 25393645DOI 10.1210/jc.2014-3718PUB-25393645

Rights unknown7 results

Eligibility

Who could join, as posted.

Sex
Female
Age
from 55 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Primary Inclusion Criteria: * The patient has a bone mineral density T-score ≤ 2.5 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA). Women with a bone mineral density T-score of 2.0 or lower and a prior low-trauma forearm, humerus, vertebral, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years, or who have an additional risk factor such as age 65 or greater or a strong maternal history of osteoporosis defined as a fracture related to osteoporosis or osteoporosis itself as determined by BMD criteria, are also study candidates. * The patient is in good general health as determined by medical history and physical examination and is without evidence of clinically significant abnormality in the opinion of the Investigator. Primary Exclusion Criteria: * History of bone disorders (e.g., Paget's disease) other than postmenopausal osteoporosis. * Prior treatment with approved or as yet unapproved bone-acting investigational agents. * History of carcinoma, nephrolithiasis or urolithiasis within the past five years or osteosarcoma at any time. * History of radiotherapy (radiation therapy).

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