Adult Idiopathic Generalized OsteoporosisPhase 2NCT02049866
Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP
A Phase 2 study testing Denosumab in people with Adult Idiopathic Generalized Osteoporosis, run by Elizabeth Shane at 2 sites in United States.
Trial summary
The purpose of this research study is to evaluate antiresorptive therapy with denosumab (Prolia) for prevention of bone loss after stopping teriparatide (TPTD) in premenopausal women with idiopathic osteoporosis. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Adult Idiopathic Generalized Osteoporosis
- What is being tested?
- Denosumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Nov 2014to 23 Dec 2021
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All women completing NCT01440803 who remain without a disease or medication that causes osteoporosis will be offered enrollment into this study.
- (Premenopausal status is no longer be required for entry.)
Who cannot join
- Renal insufficiency or liver disease: Creatinine, transaminase (AST)/alanine transaminase (ALT) above upper limit of normal
- Vitamin D deficiency: 25-hydroxyvitamin D (25-OHD) <30 ng/mL
- Pregnancy: urine pregnancy test must be negative
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbia University Medical Center
New York, New York, 10032
Creighton University
Omaha, Nebraska, 68131
About this study
Official title: Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With Idiopathic Osteoporosis (IOP)
The purpose of this research study is to evaluate antiresorptive therapy with denosumab (Prolia) for prevention of bone loss after stopping teriparatide (TPTD) in premenopausal women with idiopathic osteoporosis.
Premenopausal women who have received TPTD in the FDA Orphan Diseases Program-funded trial, "A Phase 2 Study of Teriparatide for the Treatment of Idiopathic Osteoporosis in Premenopausal Women" (NCT01440803) may be eligible to participate in the current study, a 36-month open-label pilot study of denosumab (Prolia®, 60mg subcutaneous (SC) every 6 months).
Read more
The goals of the study are to estimate the effects of denosumab on central and peripheral, as well as trabecular and cortical, bone mass and microstructure and to obtain preliminary data to inform the design of a future randomized study. This study presents the first opportunity to study the effects of denosumab after TPTD in this unique and severely affected group of young women.
Funding Source: FDA Office of Orphan Products Development (OOPD).
Read the detailed description
Osteoporosis in premenopausal women with normal menstrual function and no specific cause is termed idiopathic osteoporosis (IOP). IOP is a rare disease with an estimated prevalence of <200,000 affected premenopausal women in the United States.
Denosumab, a potent inhibitor of osteoclast-mediated bone resorption, leads to continuous gains in both trabecular and cortical bone mineral density (BMD). Moreover, denosumab is not retained in the skeleton, and may thus be preferable for use in young women who may be contemplating future pregnancies. The investigators hypothesize that denosumab, initiated after completion of two years of TPTD, will maintain or improve central and peripheral areal and volumetric BMD, microstructure and stiffness in premenopausal women with IOP.
- Being tested
- Denosumab
- Keywords
- osteoporosis, premenopausal, denosumab, idiopathic, Idiopathic Osteoporosis in Premenopausal Women
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
Also called Prolia, Xgeva
Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months
| Study group | Role | What they receive |
|---|---|---|
| Denosumab | Experimental | Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months. Receives: Drug: Denosumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Lumbar Spine Areal BMD by DXA
Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA).
Measured: Baseline and 12 months
Secondary outcomes (1)
Percent Change in Lumbar Spine Areal BMD by DXA at 24 Months
Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA).
Measured: Baseline and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study start19 Nov 2014
- Primary completion31 Mar 2020
- Study completion23 Dec 2021
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 Adult Idiopathic Generalized 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Shane
- Sponsor type
- University, hospital or other
- Collaborators
- Creighton University
- Responsible party
- Sponsor-investigator, Elizabeth Shane, Columbia University
- Investigators
- Elizabeth Shane, MD, Principal investigator, Columbia UniversityAdi Cohen, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049866
- Sponsor's protocol ID
- AAAN0161
- Other IDs
- 1R01FD005114-01A2
- Status last verified
- Oct 2022
- First submitted
- 28 Jan 2014
- Last updated
- 12 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shane E, Shiau S, Recker RR, Lappe JM, Agarwal S, Kamanda-Kosseh M, Bucovsky M, Stubby J, Cohen A. Denosumab After Teriparatide in Premenopausal Women With Idiopathic Osteoporosis. J Clin Endocrinol Metab. 2022 Mar 24;107(4):e1528-e1540. doi: 10.1210/clinem/dgab850.
PubMed 34849989
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With Idiopathic Osteoporosis (IOP)
- ClinicalTrials.gov ID
- NCT02049866
- Acronym / sponsor ID
- AAAN0161
- Keywords
- osteoporosis, premenopausal, denosumab, idiopathic, Idiopathic Osteoporosis in Premenopausal Women
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Elizabeth ShaneUniversity, hospital or other
- Collaborators
- Creighton University
- Study start
- 19 Nov 2014 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Posted 21 Apr 2021
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 research study is to evaluate antiresorptive therapy with denosumab (Prolia) for prevention of bone loss after stopping teriparatide (TPTD) in premenopausal women with idiopathic osteoporosis.
Premenopausal women who have received TPTD in the FDA Orphan Diseases Program-funded trial, "A Phase 2 Study of Teriparatide for the Treatment of Idiopathic Osteoporosis in Premenopausal Women" (NCT01440803) may be eligible to participate in the current study, a 36-month open-label pilot study of denosumab (Prolia®, 60mg subcutaneous (SC) every 6 months).
The goals of the study are to estimate the effects of denosumab on central and peripheral, as well as trabecular and cortical, bone mass and microstructure and to obtain preliminary data to inform the design of a future randomized study. This study presents the first opportunity to study the effects of denosumab after TPTD in this unique and severely affected group of young women.
Funding Source: FDA Office of Orphan Products Development (OOPD).
Detailed description
Osteoporosis in premenopausal women with normal menstrual function and no specific cause is termed idiopathic osteoporosis (IOP). IOP is a rare disease with an estimated prevalence of <200,000 affected premenopausal women in the United States.
Denosumab, a potent inhibitor of osteoclast-mediated bone resorption, leads to continuous gains in both trabecular and cortical bone mineral density (BMD). Moreover, denosumab is not retained in the skeleton, and may thus be preferable for use in young women who may be contemplating future pregnancies. The investigators hypothesize that denosumab, initiated after completion of two years of TPTD, will maintain or improve central and peripheral areal and volumetric BMD, microstructure and stiffness in premenopausal women with IOP.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Denosumab | Experimental | Drug: DenosumabDenosumab 60mg, administered every 6 months by subcutaneous injection for 36 months. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All women completing NCT01440803 who remain without a disease or medication that causes osteoporosis will be offered enrollment into this study.
- (Premenopausal status is no longer be required for entry.)
Key exclusion criteria (3 listed)
- Renal insufficiency or liver disease: Creatinine, transaminase (AST)/alanine transaminase (ALT) above upper limit of normal
- Vitamin D deficiency: 25-hydroxyvitamin D (25-OHD) <30 ng/mL
- Pregnancy: urine pregnancy test must be negative
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 |
|---|---|---|
| DenosumabAlso: Prolia, XgevaDenosumab 60mg, administered every 6 months by subcutaneous injection for 36 months | Drug | Denosumab |
Primary outcome
Percent Change in Lumbar Spine Areal BMD by DXA
Time frame: Baseline and 12 months
Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA).
1 secondary outcome
Percent Change in Lumbar Spine Areal BMD by DXA at 24 Months
Time frame: Baseline and 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34849989Shane E, Shiau S, Recker RR, Lappe JM, Agarwal S, Kamanda-Kosseh M, Bucovsky M, Stubby J, Cohen A. Denosumab After Teriparatide in Premenopausal Women With Idiopathic Osteoporosis. J Clin Endocrinol Metab. 2022 Mar 24;107(4):e1528-e1540. doi: 10.1210/clinem/dgab850.
- Columbia University, Dept of Medicine, Division of Endocrinology websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Elizabeth Shane, MD principal investigator
Columbia University
Adi Cohen, MD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Denosumab in people with Adult Idiopathic Generalized Osteoporosis, run by Elizabeth Shane at 2 sites 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 2 inclusion and 3 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 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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 21 Apr 2021). 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 in Lumbar Spine Areal BMD by DXA (time frame: Baseline and 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 NCT02049866, 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 12 Dec 2022.