OsteoporosisPhase 2NCT00542425

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

A Phase 2 study testing teriparatide, BA058 20 µg and BA058 40 µg in people with Osteoporosis, run by Radius Health, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether BA058 is effective in building bone in postmenopausal women with osteoporosis. Read more about this study

Who is it for?: Ages 55 to 85 years, women only
Conditions the study is for: Osteoporosis
What is being tested?: teriparatide, BA058 20 µg and BA058 40 µg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 222 participants
Where: 1 siteUnited States
Study dates: Apr 2007to Jun 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 85 years
Women only
No healthy volunteers
Adult, Older adult

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Radius Health, Inc.
Cambridge, Massachusetts, 02139

Other trials in United States

About this study

Official title: A Randomized, Parallel-Group, Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis

The purpose of this study is to determine whether BA058 is effective in building bone in postmenopausal women with osteoporosis.

Read the detailed description

This is a randomized, parallel-group, multi-center, dose-finding study to evaluate the effects of BA058 in the treatment of otherwise healthy postmenopausal women with osteoporosis.

Conditions: Osteoporosis
Being tested: teriparatide, Placebo, BA058 20 µg, BA058 40 µg, BA058 80 µg
Keywords: osteoporosis, postmenopausal, bone loss
Medical subject headings: Osteoporosis, Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

teriparatideDrug
Also called PTH
teriparatide 20 µg subcutaneous daily
PlaceboDrug
Placebo subcutaneous daily
BA058 20 µgDrug
BA058 20 µg subcutaneous daily
BA058 40 µgDrug
BA058 40 µg subcutaneous daily
BA058 80 µgDrug
BA058 80 µg subcutaneous daily

Study groups in NCT00542425
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
BA058 20 µg	Experimental	Not described Receives: Drug: BA058 20 µg
BA058 40 µg	Experimental	Not described Receives: Drug: BA058 40 µg
BA058 80 µg	Experimental	Not described Receives: Drug: BA058 80 µg
teriparatide	Active comparator	Not described Receives: Drug: teriparatide

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Marker of Bone Metabolism, PINP
PINP, N-terminal propeptide of type I procollagen, is a marker of anabolic bone growth.
Measured: 6 months
Change in Bone Mineral Density, Total Spine.
Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 24.
Measured: 6 months

Secondary outcomes (3)

Change in Bone Mineral Density, Femoral Neck.
Femoral neck bone mineral density (BMD) was analyzed by DXA at Week 24.
Measured: 6 months
Change in Bone Mineral Density, Total Hip.
Total analyzable hip bone mineral density (BMD) was analyzed by DXA at Week 24.
Measured: 6 months
Change in Bone Mineral Density, Total Spine.
Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 48.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Jun 2009

First posted11 Oct 2007 (estimated)
Study startApr 2007
Primary completionJun 2009
Study completionJun 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for OsteoporosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 222 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00542425
Sponsor's protocol ID: BA058-05-002
Status last verified: Sep 2017
First submitted: 10 Oct 2007
Last updated: 30 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Leder BZ, O'Dea LS, Zanchetta JR, Kumar P, Banks K, McKay K, Lyttle CR, Hattersley G. Effects of abaloparatide, a human parathyroid hormone-related peptide analog, on bone mineral density in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2015 Feb;100(2):697-706. doi: 10.1210/jc.2014-3718. Epub 2014 Nov 13.
PubMed 25393645

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoporosis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Parallel-Group, Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis
ClinicalTrials.gov ID: NCT00542425
Acronym / sponsor ID: BA058-05-002
Conditions: Osteoporosis
Keywords: osteoporosis, postmenopausal, bone loss
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 222 participants (actual)
Lead sponsor: Radius Health, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2007
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 11 Oct 2007 (estimated)
Results: Posted 29 Jul 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine whether BA058 is effective in building bone in postmenopausal women with osteoporosis.

Detailed description

This is a randomized, parallel-group, multi-center, dose-finding study to evaluate the effects of BA058 in the treatment of otherwise healthy postmenopausal women with osteoporosis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
BA058 20 µg	Experimental	Drug: BA058 20 µg
BA058 40 µg	Experimental	Drug: BA058 40 µg
BA058 80 µg	Experimental	Drug: BA058 80 µg
teriparatide	Active comparator	Drug: teriparatide

Who may qualify

Ages: 55 to 85 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
teriparatideAlso: PTHteriparatide 20 µg subcutaneous daily	Drug	teriparatide
PlaceboPlacebo subcutaneous daily	Drug	Placebo
BA058 20 µgBA058 20 µg subcutaneous daily	Drug	BA058 20 µg
BA058 40 µgBA058 40 µg subcutaneous daily	Drug	BA058 40 µg
BA058 80 µgBA058 80 µg subcutaneous daily	Drug	BA058 80 µg

Primary outcome

Change in Marker of Bone Metabolism, PINP
Time frame: 6 months
PINP, N-terminal propeptide of type I procollagen, is a marker of anabolic bone growth.
Change in Bone Mineral Density, Total Spine.
Time frame: 6 months
Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 24.

3 secondary outcomes

Change in Bone Mineral Density, Femoral Neck.
Time frame: 6 months
Change in Bone Mineral Density, Total Hip.
Time frame: 6 months
Change in Bone Mineral Density, Total Spine.
Time frame: 12 months

Results and safety

Results posted to the registry on 29 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	46	42
BA058 20 µg	43	33
BA058 40 µg	43	36
BA058 80 µg	45	34
Teriparatide	45	39

Primary outcome: Change in Marker of Bone Metabolism, PINP

Time frame: 6 months. Mean (Standard Deviation). Unit: Percent change from baseline

Measure	Placebo n = 38	BA058 20 µg n = 34	BA058 40 µg n = 37	BA058 80 µg n = 42	Teriparatide n = 42
Value	-13.1 (26.47)	20.0 (61.05)	90.8 (116.92)	97.2 (123.88)	154.3 (213.07)

Placebo vs BA058 40 µg: p <0.001, ANOVA
Placebo vs BA058 80 µg: p <0.001, ANOVA

Population analysed: The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 193 of the 221 ITT patients had data available for analysis at Week 24.

Primary outcome: Change in Bone Mineral Density, Total Spine.

Time frame: 6 months. Mean (Standard Deviation). Unit: Percent change from baseline

Measure	Placebo n = 42	BA058 20 µg n = 32	BA058 40 µg n = 37	BA058 80 µg n = 36	Teriparatide n = 40
Value	1.22 (3.211)	3.30 (2.068)	5.21 (4.427)	6.11 (3.744)	5.47 (4.218)

Placebo vs BA058 40 µg: p <0.001, ANOVA
Placebo vs BA058 80 µg: p <0.001, ANOVA

Population analysed: The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 187 of the 221 ITT patients had data available for analysis at Week 24.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 45 (2.2%)	30 of 45 (66.7%)	Not reported
BA058 20 µg	2 of 43 (4.7%)	31 of 43 (72.1%)	Not reported
BA058 40 µg	0 of 43 (0%)	32 of 43 (74.4%)	Not reported
BA058 80 µg	2 of 45 (4.4%)	33 of 45 (73.3%)	Not reported
Teriparatide	0 of 45 (0%)	35 of 45 (77.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25393645Leder BZ, O'Dea LS, Zanchetta JR, Kumar P, Banks K, McKay K, Lyttle CR, Hattersley G. Effects of abaloparatide, a human parathyroid hormone-related peptide analog, on bone mineral density in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2015 Feb;100(2):697-706. doi: 10.1210/jc.2014-3718. Epub 2014 Nov 13.

Related trials for Osteoporosis

Enrolling by invitationPhase 3
Quanduzhong Capsules for Primary Osteoporosis
Primary Osteoporosis
RecruitingObservational study
A Natural History Study of Bone and Mineral Disorders
Tumor Induced Osteomalcia, Osteomalacia
RecruitingObservational study
A Study Evaluating the Performance of Using AI Software and Chest X-rays to Screen for Osteoporosis as Compared to Standard DXA Scans in Patients 50 Years and Older
Osteoporosis, Osteopenia
RecruitingObservational study
Bone Health in Adults With Duchenne Muscular Dystrophy: A Survey on Osteoporosis, Fractures and Treatment.
Duchenne Muscular Dystrophy (DMD)
RecruitingObservational study
REMS vs DXA for Osteoporosis Diagnosis and Fracture Risk Prediction
Osteoporosis Diagnosis, Bone Health

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Radius Health, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing teriparatide, BA058 20 µg and BA058 40 µg in people with Osteoporosis, run by Radius Health, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Marker of Bone Metabolism, PINP (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00542425, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2017.