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Low Bone MassPhase 3NCT00890981

A High-resolution Peripheral Quantitative Computed Tomography Study in Postmenopausal Women Previously Treated With Denosumab

A Phase 3 study testing high-resolution peripheral quantitative computed tomography (HR-pQCT), Dual energy X-ray absorptiometry (DXA) and Denosumab in people with Low Bone Mass and Low Bone Mineral Density, run by Amgen.

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

To evaluate the combined effect of denosumab treatment and discontinuation on cortical thickness at the distal radius by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT). Read more about this study

Who is it for?
Any age, women only
What is being tested?
high-resolution peripheral quantitative computed tomography (HR-pQCT), Dual energy X-ray absorptiometry (DXA) and Denosumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
79 participants
Where
No sites listed yet
Study dates
Jul 2009to Aug 2010
Phase
Phase 3
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Ambulatory, postmenopausal women
  • Randomized to either denosumab or placebo in the 20050179 (NCT00293813) study and completed that study (ie, attended an end of study visit)
  • At least 12 months have elapsed since their end of 20050179 study visit
  • Provide signed informed consent

Who cannot join

  • Subjects who failed to receive both doses of denosumab (or SQ [subcutaneous] placebo) during the 20050179 study
  • Subjects who were randomized to the alendronate arm during the 20050179 study
  • Subjects diagnosed with any of the following conditions following completion of the 20050179 study:
  • Hyperthyroidism
  • Hyperparathyroidism
  • Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma)
Show all 14Show fewer
  • Any condition that required chronic (greater than three months cumulative and greater than 5 mg/day) glucocorticoid therapy
  • Other diseases which affect bone metabolism
  • Self-reported alcohol or drug abuse within the previous 12 months
  • Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
  • Received any investigational product other than denosumab in two years before the screening visit.
  • Received > 3 months (or equivalent) of osteoporosis treatment since having completed the 20050179 study.
  • Current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone analogue, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium or tibolone.
  • Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s) (other than Amgen trial 20080287), or subject is receiving other investigational agent(s).

About this study

Official title: A HR-pQCT Study in Postmenopausal Women Previously Treated With Denosumab

To evaluate the combined effect of denosumab treatment and discontinuation on cortical thickness at the distal radius by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT). Participants randomized to either denosumab or placebo in the 20050179 (NCT00293813) study who completed that study (ie, attended an end of study visit) can be included in this study. At least 12 months should have elapsed since the patient's 20050179 end of study visit.

Being tested
high-resolution peripheral quantitative computed tomography (HR-pQCT), Dual energy X-ray absorptiometry (DXA), Denosumab, Placebo
Medical subject headings
Bone Diseases, Metabolic, Osteoporosis, Osteoporosis, Postmenopausal

What participants receive

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

  • high-resolution peripheral quantitative computed tomography (HR-pQCT)Procedure or surgery

    Bone densitometry and microarchitecture assessments of the distal radius and the distal tibia by HR-pQCT on Day 1.

  • Dual energy X-ray absorptiometry (DXA)Procedure or surgery

    Bone densitometry assessments of the forearm by DXA on day 1.

  • DenosumabBiological

    Denosumab 60 mg subcutaneously every 6 months in the previous study

  • PlaceboDrug

    Placebo to denosumab subcutaneously every 6 months in the previous study

Study groups in NCT00890981
Study groupRoleWhat they receive
Arm 1OtherParticipants who were randomized to either denosumab or placebo in Study 20050179 and at least 12 months had elapsed from their 20050179 end-of-study visit had dual energy X-ray absorptiometry (DXA) of the forearm and HR-pQCT of the tibia and radius on Day 1 of this study. No study drug was administered.
Receives: Procedure: high-resolution peripheral quantitative computed tomography (HR-pQCT); Procedure: Dual energy X-ray absorptiometry (DXA); Biological: Denosumab; Drug: Placebo

What is being measured

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

  1. Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT

    Percent change from the 20050179 Baseline in cortical thickness at the distal radius as determined by high-resolution peripheral quantitative computed tomography (HR-pQCT) at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.

    Measured: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

Secondary outcomes (12)

  1. Percent Change From the Parent Study Baseline in Total Bone Mineral Density (BMD) at the Distal Radius by HR-pQCT

    Percent change from the 20050179 Baseline in total BMD at the distal radius as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.

    Measured: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

  2. Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Radius by HR-pQCT

    Percent change from the 20050179 Baseline in cortical BMD at the distal radius as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.

    Measured: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

  3. Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Radius by HR-pQCT

    Percent change from the 20050179 Baseline in trabecular BMD at the distal radius as determined by HR-pQCT at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.

    Measured: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

  4. Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Tibia by HR-pQCT

    Percent change from the 20050179 Baseline in cortical thickness at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.

    Measured: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

  5. Percent Change From the Parent Study Baseline in Total BMD at the Distal Tibia by HR-pQCT

    Percent change from the 20050179 Baseline in total BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.

    Measured: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

  6. Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Tibia by HR-pQCT

    Percent change from the 20050179 Baseline in cortical BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.

    Measured: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

  7. Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Tibia by HR-pQCT

    Percent change from the 20050179 Baseline in trabecular BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.

    Measured: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

  8. Percent Change of Distal 1/3 Radius BMD From the Parent Study Baseline by DXA

    Percent change of distal 1/3 radius BMD from the 20050179 Baseline as determined by dual energy X-ray absorptiometry (DXA) at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.

    Measured: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

  9. Percent Change of Ultradistal Radius BMD From the Parent Study Baseline by DXA

    Percent change of ultradistal radius BMD from the 20050179 Baseline as determined by DXA at an average of 32 months since last the subcutaneous dose of denosumab or placebo in study 20050179.

    Measured: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

  10. Percent Change of Total Radius BMD From the Parent Study Baseline by DXA

    Percent change of total radius BMD from the 20050179 Baseline as determined by DXA at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.

    Measured: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

  11. Actual Value of Serum Type I C-telopeptide

    Actual value of Serum Type I C-telopeptide measured from blood samples taken on Day 1 (an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179).

    Measured: Day 1

  12. Actual Value of Procollagen Type 1 N-terminal Peptide

    Actual value of Type 1 N-terminal Peptide as measured from blood samples taken on Day 1 (an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179).

    Measured: Day 1

Timeline

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

  1. First posted30 Apr 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJun 2010
  4. Study completionAug 2010

Resources

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 3
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00890981
Sponsor's protocol ID
20080747
Status last verified
Mar 2014
First submitted
23 Apr 2009
Last updated
2 Apr 2014
Data monitoring committee
No

Publications

  • concept.747 Treatment/discontinuation on wrist.Journal-004521;

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing high-resolution peripheral quantitative computed tomography (HR-pQCT), Dual energy X-ray absorptiometry (DXA) and Denosumab in people with Low Bone Mass and Low Bone Mineral Density, run by Amgen.

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

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. 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 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 28 Jul 2011). 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?

Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT (time frame: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.). 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 NCT00890981, 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 2 Apr 2014.

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