Postmenopausal OsteoporosisPhase 3NCT00377819
Study of Transitioning From Alendronate to Denosumab
A Phase 3 study testing alendronate and Denosumab (AMG 162) in people with Postmenopausal Osteoporosis, run by Amgen.
Trial summary
The study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab. Endpoints studied will include bone mineral density, bone turnover markers and bone histology in a subset of subjects. Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- alendronate and Denosumab (AMG 162)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Jul 2008
- 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 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal females 55 yrs or older
- Received alendronate therapy for osteoporosis for at least 6 months prior to entry into study
- Lumbar spine or total hip Bone Mineral Density (BMD) corresponding to T-score ≤ -2 and ≥ -4
Who cannot join
- Vitamin D deficiency
- Administration of intravenous bisphosphonate, or
- fluoride (except for dental treatment) or
- strontium ranelate
- Administration of Parathyroid Hormone (PTH) or Parathyroid Hormone (PTH) derivatives (eg; teriparatide) within the last year
- Administration of any bisphosphonate other than alendronate (ALN) within 1 year of screening
About this study
Official title: A Randomized Study to Evaluate Safety and Efficacy of Transitioning Therapy From Alendronate to Denosumab (AMG 162) in Postmenopausal Women With Low Bone Mineral Density
The study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab. Endpoints studied will include bone mineral density, bone turnover markers and bone histology in a subset of subjects.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- alendronate, Denosumab (AMG 162)
- Keywords
- RANKL, RANK, denosumab, AMG 162, osteoporosis, bone turnover, bone mineral density, clinical trial, postmenopausal osteoporosis, alendronate, total hip bone mineral density
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alendronateDrug
70 mg oral QW
Denosumab (AMG 162)Drug
60 mg SC q 6 mos
| Study group | Role | What they receive |
|---|---|---|
| denosumab | Experimental | Not described Receives: Drug: Denosumab (AMG 162) |
| alendronate | Active comparator | Not described Receives: Drug: alendronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Total Hip Bone Mineral Density
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100.
Measured: Baseline, 12 months
Secondary outcomes (2)
Percent Change From Baseline in Lumbar Spine Bone Mineral Density
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100.
Measured: Baseline, 12 months
Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I)
Percent Change From Baseline to Month 3 in Serum CTX-I. Percent change calculated using [(3 month value - baseline value) / baseline value]*100.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionMar 2008
- Study completionJul 2008
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 (4)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377819
- Sponsor's protocol ID
- 20050234
- Status last verified
- Jun 2011
- First submitted
- 14 Sep 2006
- Last updated
- 11 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Kendler DL, Roux C, Benhamou CL, Brown JP, Lillestol M, Siddhanti S, Man HS, San Martin J, Bone HG. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women transitioning from alendronate therapy. J Bone Miner Res. 2010 Jan;25(1):72-81. doi: 10.1359/jbmr.090716.
PubMed 19594293Miller PD, Pannacciulli N, Malouf-Sierra J, Singer A, Czerwinski E, Bone HG, Wang C, Huang S, Chines A, Lems W, Brown JP. Efficacy and safety of denosumab vs. bisphosphonates in postmenopausal women previously treated with oral bisphosphonates. Osteoporos Int. 2020 Jan;31(1):181-191. doi: 10.1007/s00198-019-05233-x. Epub 2019 Nov 28.
PubMed 31776637Gold DT, Horne R, Coon CD, Price MA, Borenstein J, Varon SF, Satram-Hoang S, Macarios D. Development, reliability, and validity of a new Preference and Satisfaction Questionnaire. Value Health. 2011 Dec;14(8):1109-16. doi: 10.1016/j.jval.2011.06.010. Epub 2011 Oct 1.
PubMed 22152181Reid IR, Miller PD, Brown JP, Kendler DL, Fahrleitner-Pammer A, Valter I, Maasalu K, Bolognese MA, Woodson G, Bone H, Ding B, Wagman RB, San Martin J, Ominsky MS, Dempster DW; Denosumab Phase 3 Bone Histology Study Group. Effects of denosumab on bone histomorphometry: the FREEDOM and STAND studies. J Bone Miner Res. 2010 Oct;25(10):2256-65. doi: 10.1002/jbmr.149.
PubMed 20533525
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Evaluate Safety and Efficacy of Transitioning Therapy From Alendronate to Denosumab (AMG 162) in Postmenopausal Women With Low Bone Mineral Density
- ClinicalTrials.gov ID
- NCT00377819
- Acronym / sponsor ID
- 20050234
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- RANKL, RANK, denosumab, AMG 162, osteoporosis, bone turnover, bone mineral density, clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 18 Sep 2006 (estimated)
- Results
- Posted 3 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab. Endpoints studied will include bone mineral density, bone turnover markers and bone histology in a subset of subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| denosumab | Experimental | Drug: Denosumab (AMG 162) |
| alendronate | Active comparator | Drug: alendronate |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal females 55 yrs or older
- Received alendronate therapy for osteoporosis for at least 6 months prior to entry into study
- Lumbar spine or total hip Bone Mineral Density (BMD) corresponding to T-score ≤ -2 and ≥ -4
Key exclusion criteria (6 listed)
- Vitamin D deficiency
- Administration of intravenous bisphosphonate, or
- fluoride (except for dental treatment) or
- strontium ranelate
- Administration of Parathyroid Hormone (PTH) or Parathyroid Hormone (PTH) derivatives (eg; teriparatide) within the last year
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 |
|---|---|---|
| alendronate70 mg oral QW | Drug | alendronate |
| Denosumab (AMG 162)60 mg SC q 6 mos | Drug | denosumab |
Primary outcome
Percent Change From Baseline in Total Hip Bone Mineral Density
Time frame: Baseline, 12 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100.
2 secondary outcomes
Percent Change From Baseline in Lumbar Spine Bone Mineral Density
Time frame: Baseline, 12 months
Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I)
Time frame: Baseline, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19594293Kendler DL, Roux C, Benhamou CL, Brown JP, Lillestol M, Siddhanti S, Man HS, San Martin J, Bone HG. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women transitioning from alendronate therapy. J Bone Miner Res. 2010 Jan;25(1):72-81. doi: 10.1359/jbmr.090716.
- Derived from this study: PubMed 31776637Miller PD, Pannacciulli N, Malouf-Sierra J, Singer A, Czerwinski E, Bone HG, Wang C, Huang S, Chines A, Lems W, Brown JP. Efficacy and safety of denosumab vs. bisphosphonates in postmenopausal women previously treated with oral bisphosphonates. Osteoporos Int. 2020 Jan;31(1):181-191. doi: 10.1007/s00198-019-05233-x. Epub 2019 Nov 28.
- Derived from this study: PubMed 22152181Gold DT, Horne R, Coon CD, Price MA, Borenstein J, Varon SF, Satram-Hoang S, Macarios D. Development, reliability, and validity of a new Preference and Satisfaction Questionnaire. Value Health. 2011 Dec;14(8):1109-16. doi: 10.1016/j.jval.2011.06.010. Epub 2011 Oct 1.
- Derived from this study: PubMed 20533525Reid IR, Miller PD, Brown JP, Kendler DL, Fahrleitner-Pammer A, Valter I, Maasalu K, Bolognese MA, Woodson G, Bone H, Ding B, Wagman RB, San Martin J, Ominsky MS, Dempster DW; Denosumab Phase 3 Bone Histology Study Group. Effects of denosumab on bone histomorphometry: the FREEDOM and STAND studies. J Bone Miner Res. 2010 Oct;25(10):2256-65. doi: 10.1002/jbmr.149.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing alendronate and Denosumab (AMG 162) in people with Postmenopausal Osteoporosis, 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 3 inclusion and 6 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 11 Jul 2011. 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 3 Aug 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?
Percent Change From Baseline in Total Hip Bone Mineral Density (time frame: Baseline, 12 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 NCT00377819, which also lists 4 linked publications.
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 11 Jul 2011.