OsteoporosisPhase 2NCT00000400
Alendronate and/or Parathyroid Hormone for Osteoporosis
A Phase 2 study testing Human parathyroid hormone [hPTH-(1-34)] and alendronate in people with Osteoporosis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study looks at the effects of two medications, alendronate and parathyroid hormone, on bone mass and on bone formation and bone breakdown in women with osteoporosis. We will randomly select postmenopausal women who have osteoporosis to receive laboratory-produced human parathyroid hormone (hPTH), or alendronate… Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Human parathyroid hormone [hPTH-(1-34)] and alendronate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1999to Jun 2006
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lumbar spine or hip BMD T-score less than or equal to minus 2.0
- Postmenopausal at least 5 years
- Fully ambulatory
- Able to give informed consent
Who cannot join
- No concurrent illnesses that cause bone loss
- No recent drug treatment for osteoporosis
- No recent fracture
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Bone Formation-Resorption Coupling and Osteoporosis
This study looks at the effects of two medications, alendronate and parathyroid hormone, on bone mass and on bone formation and bone breakdown in women with osteoporosis. We will randomly select postmenopausal women who have osteoporosis to receive laboratory-produced human parathyroid hormone (hPTH), or alendronate, or both for 2.5 years. Study participants will return to the study center periodically to have their bone mass measured and to give blood and urine samples for tests of bone formation and breakdown and for other laboratory tests. Those who complete the study are eligible for one or two 12 month extension studies.
Read the detailed description
This is a randomized, prospective, open-label study in which osteoporotic postmenopausal women self-administer synthetic hPTH-(1-34), alendronate, or both, every day for 2.5 years. Participants initially come to Massachusetts General Hospital once a month, and subsequently once every 3-6 months, for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass. One-third of the participants take hPTH-(1-34) daily, one-third take alendronate once daily, and one-third take both daily (Phase A, months 0-30).
Participants who complete Phase A are eligible for a 12 month extension study (Phase B, months 30-42), during which any alendronate treatment is continued without change and any hPTH 1-34 treatment is stopped.
Participants who complete Phase B are eligible for a second 12 month extension study (Phase C, months 42-54), during which any alendronate treatment is continued without change and every participant takes hPTH 1-34.
During Phases B and C, these participants come to Massachusetts General Hospital once every 6 months for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass.
- Conditions
- Osteoporosis
- Being tested
- Human parathyroid hormone [hPTH-(1-34)], alendronate
- Keywords
- Osteoporosis, Bone formation, Bone resorption, Parathyroid hormone (PTH), Postmenopause
- Medical subject headings
- Osteoporosis, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human parathyroid hormone [hPTH-(1-34)]Drug
Also called teriparatide
37 mcg once daily by self-administered sc injection
alendronateDrug
Also called Fosamax
70 mg/week by oral route
| Study group | Role | What they receive |
|---|---|---|
| PTH | Experimental | Human parathyroid hormone [hPTH-(1-34)] Receives: Drug: Human parathyroid hormone [hPTH-(1-34)] |
| ALN | Active comparator | Alendronate Receives: Drug: alendronate |
| PTH+ALN | Experimental | Human parathyroid hormone [hPTH-(1-34)] plus alendronate Receives: Drug: Human parathyroid hormone [hPTH-(1-34)]; Drug: alendronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in spine bone mineral density
Measured: study months 30 (phase A), 42 (phase B), 54 (phase C)
Secondary outcomes (10)
change in hip bone mineral density
Measured: study months 30 (phase A), 42 (phase B), 54 (phase C)
change in forearm bone mineral density
Measured: study months 30 (phase A), 42 (phase B), 54 (phase C)
change in total body bone mineral
Measured: study months 30 (phase A), 42 (phase B), 54 (phase C)
change in femoral shaft bone mineral density
Measured: study months 30 (phase A), 42 (phase B), 54 (phase C)
change in serum PINP
Measured: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
change in serum osteocalcin
Measured: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
change in serum NTX
Measured: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
incidence of hypercalcemia
Measured: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
incidence of hypercalciuria
Measured: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
incidence of symptoms
Measured: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startAug 1999
- Primary completionApr 2006
- Study completionJun 2006
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Robert M. Neer, MD, Massachusetts General Hospital
- Investigators
- Robert M. Neer, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000400
- Sponsor's protocol ID
- P50 AR44855 NIAMS-023
- Other IDs
- P50AR044855
- Status last verified
- Dec 2013
- First submitted
- 3 Nov 1999
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Finkelstein JS, Wyland JJ, Leder BZ, Burnett-Bowie SM, Lee H, Juppner H, Neer RM. Effects of teriparatide retreatment in osteoporotic men and women. J Clin Endocrinol Metab. 2009 Jul;94(7):2495-501. doi: 10.1210/jc.2009-0154. Epub 2009 Apr 28.
PubMed 19401368
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Formation-Resorption Coupling and Osteoporosis
- ClinicalTrials.gov ID
- NCT00000400
- Acronym / sponsor ID
- P50 AR44855 NIAMS-023
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, Bone formation, Bone resorption, Parathyroid hormone (PTH), Postmenopause
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Aug 1999
- Primary completion
- Apr 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 4 Nov 1999 (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 study looks at the effects of two medications, alendronate and parathyroid hormone, on bone mass and on bone formation and bone breakdown in women with osteoporosis. We will randomly select postmenopausal women who have osteoporosis to receive laboratory-produced human parathyroid hormone (hPTH), or alendronate, or both for 2.5 years. Study participants will return to the study center periodically to have their bone mass measured and to give blood and urine samples for tests of bone formation and breakdown and for other laboratory tests. Those who complete the study are eligible for one or two 12 month extension studies.
Detailed description
This is a randomized, prospective, open-label study in which osteoporotic postmenopausal women self-administer synthetic hPTH-(1-34), alendronate, or both, every day for 2.5 years. Participants initially come to Massachusetts General Hospital once a month, and subsequently once every 3-6 months, for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass. One-third of the participants take hPTH-(1-34) daily, one-third take alendronate once daily, and one-third take both daily (Phase A, months 0-30).
Participants who complete Phase A are eligible for a 12 month extension study (Phase B, months 30-42), during which any alendronate treatment is continued without change and any hPTH 1-34 treatment is stopped.
Participants who complete Phase B are eligible for a second 12 month extension study (Phase C, months 42-54), during which any alendronate treatment is continued without change and every participant takes hPTH 1-34.
During Phases B and C, these participants come to Massachusetts General Hospital once every 6 months for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PTH | Experimental | Drug: Human parathyroid hormone [hPTH-(1-34)]Human parathyroid hormone [hPTH-(1-34)] |
| ALN | Active comparator | Drug: alendronateAlendronate |
| PTH+ALN | Experimental | Drug: Human parathyroid hormone [hPTH-(1-34)], Drug: alendronateHuman parathyroid hormone [hPTH-(1-34)] plus alendronate |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Lumbar spine or hip BMD T-score less than or equal to minus 2.0
- Postmenopausal at least 5 years
- Fully ambulatory
- Able to give informed consent
Key exclusion criteria (3 listed)
- No concurrent illnesses that cause bone loss
- No recent drug treatment for osteoporosis
- No recent fracture
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 |
|---|---|---|
| Human parathyroid hormone [hPTH-(1-34)]Also: teriparatide37 mcg once daily by self-administered sc injection | Drug | PTH, PTH+ALN |
| alendronateAlso: Fosamax70 mg/week by oral route | Drug | ALN, PTH+ALN |
Primary outcome
change in spine bone mineral density
Time frame: study months 30 (phase A), 42 (phase B), 54 (phase C)
10 secondary outcomes
change in hip bone mineral density
Time frame: study months 30 (phase A), 42 (phase B), 54 (phase C)
change in forearm bone mineral density
Time frame: study months 30 (phase A), 42 (phase B), 54 (phase C)
change in total body bone mineral
Time frame: study months 30 (phase A), 42 (phase B), 54 (phase C)
change in femoral shaft bone mineral density
Time frame: study months 30 (phase A), 42 (phase B), 54 (phase C)
change in serum PINP
Time frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
change in serum osteocalcin
Time frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
change in serum NTX
Time frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
incidence of hypercalcemia
Time frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
incidence of hypercalciuria
Time frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
incidence of symptoms
Time frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2013.
- Derived from this study: PubMed 19401368Finkelstein JS, Wyland JJ, Leder BZ, Burnett-Bowie SM, Lee H, Juppner H, Neer RM. Effects of teriparatide retreatment in osteoporotic men and women. J Clin Endocrinol Metab. 2009 Jul;94(7):2495-501. doi: 10.1210/jc.2009-0154. Epub 2009 Apr 28.
- Click here for more information about this study.Link 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.
Robert M. Neer, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human parathyroid hormone [hPTH-(1-34)] and alendronate in people with 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 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 9 Dec 2013. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change in spine bone mineral density (time frame: study months 30 (phase A), 42 (phase B), 54 (phase C)). 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 NCT00000400, 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 9 Dec 2013.