OsteoporosisPhase 4NCT02130973
The Treatment of Osteoporosis Using a Combination of Teriparatide (Forteo) and Denosumab
A Phase 4 study testing Standard Clinical Practice Regimen and Experimental Cyclic Regimen in people with Osteoporosis, run by Health Research, Inc. at 1 site in United States.
Trial summary
This is a three-year study to evaluate the effect of sequential therapy of Forteo (teriparatide) and denosumab on bone density at the spine, hip, leg and forearm. Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Standard Clinical Practice Regimen and Experimental Cyclic Regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Aug 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- The use of drugs known to affect skeletal or calcium homeostasis.
- Multiple vertebral fractures or severe lumbar degenerative changes with fewer than 2 evaluable lumbar vertebrae
- Current use of anti-resorptive medicines
- Use of Hormone/Estrogen Therapy, raloxifene or calcitonin within the past 3 months
- Use of oral bisphosphonate for more than 4 months within the past 2 years or more than 5 years total cumulative bisphosphonate use in the past 10 years
- Use of intravenous ibandronate within the past 18 months
Show all 17Show fewer
- Use of intravenous zoledronic acid within the past 4 years
- A history of a symptomatic renal stone within the past 3 years or history of multiple symptomatic renal stones
- Skeletal Disorders other than osteoporosis including: Hypercalcemia, hyperparathyroidism, Paget's Disease or osteomalacia
- Untreated or uncontrolled thyroid disease
- Elevated Bone Specific Alkaline Phosphatase level
- History of external or internal radiation therapy
- Renal insufficiency with estimated GFR below 30 ml/min
- Liver function tests (ALT/AST) more than 1.5 times the upper limit of normal
- Clinically significant hyperuricemia or active gout
- Any contraindications to receipt of Teriparatide or Denosumab (including hypocalcemia)
- History of an atypical fracture of the femoral shaft
Trial locations and contacts
1 site in 1 country.
United States1 site
Helen Hayes Hospital
West Haverstraw, New York, 10993
About this study
This is a three-year study to evaluate the effect of sequential therapy of Forteo (teriparatide) and denosumab on bone density at the spine, hip, leg and forearm.
Read the detailed description
In order to maximize the early anabolic effect with teriparatide (TPTD), and to avoid the development of tachyphylaxis to the continued daily administration of TPTD beyond 6 months, cyclic therapy might be optimal. Since Denosumab (Prolia) is a potent antiresorptive agent with a rapid off-effect, it might be the optimal agent to help maximize bone gains with cyclic TPTD/antiresorptive therapy. Our primary hypothesis is that the increment in bone density of the spine by DXA will be greater in women randomized to receive the cyclic sequential regimen (three separate 6 month cycles of daily subcutaneous TPTD, each followed by one subcutaneous injection of Denosumab) compared with daily sequential therapy (18 months of daily subcutaneous TPTD followed by Denosumab therapy for 18 months).
- Conditions
- Osteoporosis
- Being tested
- Standard Clinical Practice Regimen, Experimental Cyclic Regimen
- Keywords
- teriparatide, Forteo, Denosumab, Prolia, bone density, treatment
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Clinical Practice RegimenDrug
Also called 18 months Forteo followed by 18 months Prolia
Standard Clinical Practice Regimen
Experimental Cyclic RegimenDrug
Also called three separate 6 month cycles of daily Forteo, each followed by one of Prolia
Experimental Cyclic Regimen
| Study group | Role | What they receive |
|---|---|---|
| Standard Clinical Practice Regimen | Active comparator | Standard Clinical Practice (Daily) Regimen: 18 months of daily subcutaneous Forteo followed by denosumab therapy for 18 months (18 months of Forteo then 3 injections of Prolia at 18, 24 and 30 months). Receives: Drug: Standard Clinical Practice Regimen |
| Experimental (cyclic) regimen | Experimental | Experimental (Cyclic) Regimen: three separate 6-month cycles of daily subcutaneous Forteo, each followed by one subcutaneous injection of Prolia (Forteo from 0 to 6 months, and then from 12 to 18 months and then from 24 to 30 months, for a total dose of 18 months; 3 injections of Prolia at 6, 18 and 30 months). Receives: Drug: Experimental Cyclic Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
spine bone density
Measured: 3 years
Secondary outcomes (1)
bone mineral density of the hip, wrist, total body and lateral spine and CT of arm and leg
Bone mineral density testing of multiple skeletal sites and peripheral QCT with high resolution of the leg and arm
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startAug 2013
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felicia Cosman, M.D., Health Research, Inc.
- Investigators
- Felicia Cosman, M.D., Principal investigator, Helen Hayes Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130973
- Sponsor's protocol ID
- AMG 10-05
- Status last verified
- Aug 2017
- First submitted
- 2 May 2014
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cosman F, McMahon D, Dempster D, Nieves JW. Standard Versus Cyclic Teriparatide and Denosumab Treatment for Osteoporosis: A Randomized Trial. J Bone Miner Res. 2020 Feb;35(2):219-225. doi: 10.1002/jbmr.3850. Epub 2019 Oct 23.
PubMed 31419313
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Osteoporosis Using a Combination of Teriparatide (Forteo) and Denosumab
- ClinicalTrials.gov ID
- NCT02130973
- Acronym / sponsor ID
- AMG 10-05
- Conditions
- Osteoporosis
- Keywords
- teriparatide, Forteo, Denosumab, Prolia, bone density, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Health Research, Inc.University, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 6 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a three-year study to evaluate the effect of sequential therapy of Forteo (teriparatide) and denosumab on bone density at the spine, hip, leg and forearm.
Detailed description
In order to maximize the early anabolic effect with teriparatide (TPTD), and to avoid the development of tachyphylaxis to the continued daily administration of TPTD beyond 6 months, cyclic therapy might be optimal. Since Denosumab (Prolia) is a potent antiresorptive agent with a rapid off-effect, it might be the optimal agent to help maximize bone gains with cyclic TPTD/antiresorptive therapy. Our primary hypothesis is that the increment in bone density of the spine by DXA will be greater in women randomized to receive the cyclic sequential regimen (three separate 6 month cycles of daily subcutaneous TPTD, each followed by one subcutaneous injection of Denosumab) compared with daily sequential therapy (18 months of daily subcutaneous TPTD followed by Denosumab therapy for 18 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Clinical Practice Regimen | Active comparator | Drug: Standard Clinical Practice RegimenStandard Clinical Practice (Daily) Regimen: 18 months of daily subcutaneous Forteo followed by denosumab therapy for 18 months (18 months of Forteo then 3 injections of Prolia at 18, 24 and 30 months). |
| Experimental (cyclic) regimen | Experimental | Drug: Experimental Cyclic RegimenExperimental (Cyclic) Regimen: three separate 6-month cycles of daily subcutaneous Forteo, each followed by one subcutaneous injection of Prolia (Forteo from 0 to 6 months, and then from 12 to 18 months and then from 24 to 30 months, for a total dose of 18 months; 3 injections of Prolia at 6, 18 and 30 months). |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- The use of drugs known to affect skeletal or calcium homeostasis.
- Multiple vertebral fractures or severe lumbar degenerative changes with fewer than 2 evaluable lumbar vertebrae
- Current use of anti-resorptive medicines
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 |
|---|---|---|
| Standard Clinical Practice RegimenAlso: 18 months Forteo followed by 18 months ProliaStandard Clinical Practice Regimen | Drug | Standard Clinical Practice Regimen |
| Experimental Cyclic RegimenAlso: three separate 6 month cycles of daily Forteo, each followed by one of ProliaExperimental Cyclic Regimen | Drug | Experimental (cyclic) regimen |
Primary outcome
spine bone density
Time frame: 3 years
1 secondary outcome
bone mineral density of the hip, wrist, total body and lateral spine and CT of arm and leg
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- Derived from this study: PubMed 31419313Cosman F, McMahon D, Dempster D, Nieves JW. Standard Versus Cyclic Teriparatide and Denosumab Treatment for Osteoporosis: A Randomized Trial. J Bone Miner Res. 2020 Feb;35(2):219-225. doi: 10.1002/jbmr.3850. Epub 2019 Oct 23.
- Individual participant dataSharing planned: No
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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.
Felicia Cosman, M.D. principal investigator
Helen Hayes Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard Clinical Practice Regimen and Experimental Cyclic Regimen in people with Osteoporosis, run by Health Research, 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?
The sponsor lists 0 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 31 Aug 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
spine bone density (time frame: 3 years). 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 NCT02130973, 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 31 Aug 2017.