Postmenopausal OsteoporosisPhase 4NCT01750086
Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption
A Phase 4 study testing Teriparatide 40-mcg subcutaneous injection, Denosumab Injection and Alendronate Oral Tablet in people with Postmenopausal Osteoporosis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide. 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
- Postmenopausal Osteoporosis
- What is being tested?
- Teriparatide 40-mcg subcutaneous injection, Denosumab Injection and Alendronate Oral Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Aug 2014
- Phase
- Phase 4
- 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 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must satisfy A and B and C below:
- Women aged 45+
- Postmenopausal
- Osteoporotic with high risk of fracture
Who cannot join
- History of significant hepatic, renal, cardiovascular, malignant disease, or conditions with impaired immune system
- Current alcohol or substance abuse
- Major psychiatric disorders
- Abnormal calcium level, elevated PTH, vitamin D deficiency, or anemia
- Known congenital or acquired bone disease other than osteoporosis
- Current use or past use in the past 12 months of oral bisphosphonates
Show all 13Show fewer
- Current use or use in the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin
- Use of oral or parenteral glucocorticoids for more than 14 days in the past 6 months
- Any current or previous use of strontium or intravenous bisphosphonates
- Sensitivity to cell-derived drug products or teriparatide
- Extensive dental work involving dental extraction or dental implant within the past 2 months or in the upcoming 2 months
- Inability to sit upright for 30 minutes
- Esophageal abnormalities
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Teriparatide 40-mcg subcutaneous injection, Denosumab Injection, Alendronate Oral Tablet
- Keywords
- osteoporosis, postmenopausal, denosumab, teriparatide, alendronate, Forteo®, Prolia®
- 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.
Teriparatide 40-mcg subcutaneous injectionDrug
Also called Forteo®
Denosumab InjectionDrug
One-time Denosumab injection
Alendronate Oral TabletDrug
weekly alendronate for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Denosumab 60mg subcutaneous injection | Active comparator | Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. Receives: Drug: Teriparatide 40-mcg subcutaneous injection; Drug: Denosumab Injection |
| Alendronate 70mg weekly x 8 weeks | Active comparator | Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. Receives: Drug: Teriparatide 40-mcg subcutaneous injection; Drug: Alendronate Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Turnover Marker (Blood Sample)
The primary outcome was the between-group difference in the teriparatide-induced change in serum c-telopeptide from baseline to week 8.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionApr 2014
- Study completionAug 2014
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 (6)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 Massachusetts General HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Leder, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750086
- Sponsor's protocol ID
- 2012P001956
- Status last verified
- Feb 2017
- First submitted
- 26 Nov 2012
- Last updated
- 27 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Cosman F, Eriksen EF, Recknor C, Miller PD, Guanabens N, Kasperk C, Papanastasiou P, Readie A, Rao H, Gasser JA, Bucci-Rechtweg C, Boonen S. Effects of intravenous zoledronic acid plus subcutaneous teriparatide [rhPTH(1-34)] in postmenopausal osteoporosis. J Bone Miner Res. 2011 Mar;26(3):503-11. doi: 10.1002/jbmr.238.
PubMed 20814967Finkelstein JS, Hayes A, Hunzelman JL, Wyland JJ, Lee H, Neer RM. The effects of parathyroid hormone, alendronate, or both in men with osteoporosis. N Engl J Med. 2003 Sep 25;349(13):1216-26. doi: 10.1056/NEJMoa035725. Epub 2003 Sep 20.
PubMed 14500805Cosman F, Nieves J, Zion M, Woelfert L, Luckey M, Lindsay R. Daily and cyclic parathyroid hormone in women receiving alendronate. N Engl J Med. 2005 Aug 11;353(6):566-75. doi: 10.1056/NEJMoa050157.
PubMed 16093465Kostenuik PJ, Capparelli C, Morony S, Adamu S, Shimamoto G, Shen V, Lacey DL, Dunstan CR. OPG and PTH-(1-34) have additive effects on bone density and mechanical strength in osteopenic ovariectomized rats. Endocrinology. 2001 Oct;142(10):4295-304. doi: 10.1210/endo.142.10.8437.
PubMed 11564687Finkelstein JS, Wyland JJ, Lee H, Neer RM. Effects of teriparatide, alendronate, or both in women with postmenopausal osteoporosis. J Clin Endocrinol Metab. 2010 Apr;95(4):1838-45. doi: 10.1210/jc.2009-1703. Epub 2010 Feb 17.
PubMed 20164296Tsai JN, Zhu Y, Foley K, Lee H, Burnett-Bowie SA, Neer RM, Leder BZ. Comparative Resistance to Teriparatide-Induced Bone Resorption With Denosumab or Alendronate. J Clin Endocrinol Metab. 2015 Jul;100(7):2718-23. doi: 10.1210/jc.2015-1541. Epub 2015 May 1.
PubMed 25933031
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption
- ClinicalTrials.gov ID
- NCT01750086
- Acronym / sponsor ID
- 2012P001956
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- osteoporosis, postmenopausal, denosumab, teriparatide, alendronate, Forteo®, Prolia®
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Posted 1 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denosumab 60mg subcutaneous injection | Active comparator | Drug: Teriparatide 40-mcg subcutaneous injection, Drug: Denosumab InjectionEach subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. |
| Alendronate 70mg weekly x 8 weeks | Active comparator | Drug: Teriparatide 40-mcg subcutaneous injection, Drug: Alendronate Oral TabletEach subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged 45+
- Postmenopausal
- Osteoporotic with high risk of fracture
Key exclusion criteria (13 listed)
- History of significant hepatic, renal, cardiovascular, malignant disease, or conditions with impaired immune system
- Current alcohol or substance abuse
- Major psychiatric disorders
- Abnormal calcium level, elevated PTH, vitamin D deficiency, or anemia
- Known congenital or acquired bone disease other than osteoporosis
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 |
|---|---|---|
| Teriparatide 40-mcg subcutaneous injectionAlso: Forteo® | Drug | Alendronate 70mg weekly x 8 weeks, Denosumab 60mg subcutaneous injection |
| Denosumab InjectionOne-time Denosumab injection | Drug | Denosumab 60mg subcutaneous injection |
| Alendronate Oral Tabletweekly alendronate for 8 weeks | Drug | Alendronate 70mg weekly x 8 weeks |
Primary outcome
Bone Turnover Marker (Blood Sample)
Time frame: 8 weeks
The primary outcome was the between-group difference in the teriparatide-induced change in serum c-telopeptide from baseline to week 8.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20814967Cosman F, Eriksen EF, Recknor C, Miller PD, Guanabens N, Kasperk C, Papanastasiou P, Readie A, Rao H, Gasser JA, Bucci-Rechtweg C, Boonen S. Effects of intravenous zoledronic acid plus subcutaneous teriparatide [rhPTH(1-34)] in postmenopausal osteoporosis. J Bone Miner Res. 2011 Mar;26(3):503-11. doi: 10.1002/jbmr.238.
- Background: PubMed 14500805Finkelstein JS, Hayes A, Hunzelman JL, Wyland JJ, Lee H, Neer RM. The effects of parathyroid hormone, alendronate, or both in men with osteoporosis. N Engl J Med. 2003 Sep 25;349(13):1216-26. doi: 10.1056/NEJMoa035725. Epub 2003 Sep 20.
- Background: PubMed 16093465Cosman F, Nieves J, Zion M, Woelfert L, Luckey M, Lindsay R. Daily and cyclic parathyroid hormone in women receiving alendronate. N Engl J Med. 2005 Aug 11;353(6):566-75. doi: 10.1056/NEJMoa050157.
- Background: PubMed 11564687Kostenuik PJ, Capparelli C, Morony S, Adamu S, Shimamoto G, Shen V, Lacey DL, Dunstan CR. OPG and PTH-(1-34) have additive effects on bone density and mechanical strength in osteopenic ovariectomized rats. Endocrinology. 2001 Oct;142(10):4295-304. doi: 10.1210/endo.142.10.8437.
- Background: PubMed 20164296Finkelstein JS, Wyland JJ, Lee H, Neer RM. Effects of teriparatide, alendronate, or both in women with postmenopausal osteoporosis. J Clin Endocrinol Metab. 2010 Apr;95(4):1838-45. doi: 10.1210/jc.2009-1703. Epub 2010 Feb 17.
- Derived from this study: PubMed 25933031Tsai JN, Zhu Y, Foley K, Lee H, Burnett-Bowie SA, Neer RM, Leder BZ. Comparative Resistance to Teriparatide-Induced Bone Resorption With Denosumab or Alendronate. J Clin Endocrinol Metab. 2015 Jul;100(7):2718-23. doi: 10.1210/jc.2015-1541. Epub 2015 May 1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Teriparatide 40-mcg subcutaneous injection, Denosumab Injection and Alendronate Oral Tablet in people with Postmenopausal Osteoporosis, run by Massachusetts General Hospital 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 4 inclusion and 13 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 27 Mar 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?
Yes. Results are posted in the registry (first posted 1 Dec 2016). 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?
Bone Turnover Marker (Blood Sample) (time frame: 8 weeks). 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 NCT01750086, which also lists 6 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 27 Mar 2017.