OsteoporosisPhase 2NCT00005005
PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis
A Phase 2 study testing PTH and Alendronate in people with Osteoporosis, run by Dennis Black at 4 sites in United States.
Trial summary
This 2-year study will test the effectiveness of combining parathyroid hormone (PTH) and alendronate for treating osteoporosis in postmenopausal women. Alendronate is a drug used to treat osteoporosis and primarily prevents bone loss, whereas PTH increases bone formation. Read more about this study
- Who is it for?
- Ages 55 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- PTH and Alendronate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 1999to Nov 2007
- 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 55 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 55 and 85 years
- Postmenopausal (have not had any menses in the last 5 years)
- Have a bone mineral density scan (DXA) that can be evaluated at the spine AND at the hip with a T-score equal to or below -2.5 at the spine or the femoral neck or total hip OR T-score equal to or below -2.0 at the spine or the femoral neck or total hip and have at least one of the following risk factors for fracture: (a) age > 65 years; (b) history of postmenopausal fracture (nonvertebral or vertebral); or (c) maternal history of hip fracture
- Willing and able to self-administer daily injections
Who cannot join
- Have used estrogen (oral or patch) for more than 1 month in the last 6 months or more than 12 months in the last 2 years
- History of more than 12 months of bisphosphonate use ever, or any use (> 4 weeks) within the past 12 months
- History of rhPTH (recombinant human PTH) use
- Any major life-threatening illnesses
- Type 1 or uncontrolled type 2 diabetes mellitus (defined as hemoglobin A1C > 10.0), or currently using insulin
- Vitamin D level < 15 nanograms/ml
Show all 25Show fewer
- History of kidney disease (creatinine > 2.0 mg/dl)
- Renal insufficiency (creatinine clearance < 40 mg/min)
- Any history of kidney stones
- Any history of hypercalciuria or currently have urine calcium/creatinine >300 mg
- History of hypercalcemia, sarcoidosis, or hyperparathyroidism
- History of active or treated tuberculosis or other granulomatous disorders
- History of breast cancer, melanoma, or hematologic malignancy that has required treatment within the last 10 years
- History of bone cancer or any other metabolic bone disease that has required treatment within the last 10 years
- History of any other nonskin cancer that has required treatment within the last 10 years
- History of symptomatic esophageal reflux, achalasia or esophageal stricture
- Currently taking > 7.5 mg systemic prednisone or equivalent per day
- Currently using > two puffs, four times/day of inhaled steroids
- Currently taking anticoagulants or anticonvulsants
- Have used Calcitonin within the past 3 months
- Have used Raloxifene in the last 6 months or for more than 12 months in the last 2 years
- Have used Tamoxifen in the last 6 months or for more than 12 months in the last 2 years
- Have used fluoride for at least a month within the past 5 years
- Currently taking > 1000 IU/day vitamin D or vitamin D analogues or metabolites
- Currently taking thyroid hormone replacement AND have a TSH < 0.1mIU/L
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Maine Center for Osteoporosis
Bangor, Maine, 04401
University of Minnesota
Minneapolis, Minnesota, 55415
Columbia University
New York, New York, 10032
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Clinical Trial of Parathyroid Hormone (PTH) and Alendronate in Combination in the Treatment of Osteoporosis
This 2-year study will test the effectiveness of combining parathyroid hormone (PTH) and alendronate for treating osteoporosis in postmenopausal women. Alendronate is a drug used to treat osteoporosis and primarily prevents bone loss, whereas PTH increases bone formation. We will treat the study participants either with PTH and alendronate, alendronate alone, or PTH alone. We will determine the effects of these treatments by looking for changes in bone mineral density in the hip and spine.
Read the detailed description
The PaTH study is a 2-year, multicenter, double-blind, placebo-controlled trial to test the efficacy of combining hPTH (1-84) and alendronate for treating osteoporosis in postmenopausal women.
238 women were randomized between 55 and 85 years of age to receive either: (1) PTH for 1 year followed by alendronate for 1 year; (2) PTH and alendronate for 1 year followed by alendronate for 1 year; (3) alendronate for 2 years; or (4) PTH for 1 year followed by placebo for 1 year. The primary endpoints are changes in bone mineral density at several sites and changes in biochemical markers.
In addition, we will assess specific biochemical markers of bone turnover (e.g., osteocalcin, deoxypridinoline, N-telopeptide, bone-specific alkaline phosphatase and bone sialoprotein) to determine if they can predict the skeletal response to combination therapy. We will also determine whether PTH positively affects ultrasound measurements in the calcaneus.
- Conditions
- Osteoporosis
- Being tested
- PTH, Alendronate
- Keywords
- PTH, Alendronate, Parathyroid hormone, Osteoporosis, Postmenopausal
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTHDrug
AlendronateDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive PTH for 1 year followed by alendronate for 1 year. Receives: Drug: PTH; Drug: Alendronate |
| 2 | Experimental | Participants will receive PTH and alendronate for 1 year followed by alendronate for 1 year. Receives: Drug: PTH; Drug: Alendronate |
| 3 | Experimental | Participants will receive alendronate for 2 years. Receives: Drug: Alendronate |
| 4 | Active comparator | Participants will receive PTH for 1 year followed by placebo for 1 year. Receives: Drug: PTH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in bone mineral density at several sites and changes in biochemical markers
Measured: Year 2
Secondary outcomes (1)
Predictive value of specific biochemical markers of bone turnover
Measured: Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2000 (estimated)
- Study startOct 1999
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dennis Black
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor-investigator, Dennis Black, University of California, San Francisco
- Investigators
- Dennis Black, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005005
- Sponsor's protocol ID
- N01 AR92245
- Other IDs
- N01AR002245-000, NIAMS-045
- Status last verified
- Feb 2013
- First submitted
- 24 Mar 2000
- Last updated
- 5 Feb 2013
- Results posted
- No
Publications
Black DM, Greenspan SL, Ensrud KE, Palermo L, McGowan JA, Lang TF, Garnero P, Bouxsein ML, Bilezikian JP, Rosen CJ; PaTH Study Investigators. The effects of parathyroid hormone and alendronate alone or in combination in postmenopausal osteoporosis. N Engl J Med. 2003 Sep 25;349(13):1207-15. doi: 10.1056/NEJMoa031975. Epub 2003 Sep 20.
PubMed 14500804Black DM, Bilezikian JP, Ensrud KE, Greenspan SL, Palermo L, Hue T, Lang TF, McGowan JA, Rosen CJ; PaTH Study Investigators. One year of alendronate after one year of parathyroid hormone (1-84) for osteoporosis. N Engl J Med. 2005 Aug 11;353(6):555-65. doi: 10.1056/NEJMoa050336.
PubMed 16093464Bauer DC, Garnero P, Bilezikian JP, Greenspan SL, Ensrud KE, Rosen CJ, Palermo L, Black DM. Short-term changes in bone turnover markers and bone mineral density response to parathyroid hormone in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2006 Apr;91(4):1370-5. doi: 10.1210/jc.2005-1712. Epub 2006 Jan 31.
PubMed 16449339Sellmeyer DE, Black DM, Palermo L, Greenspan S, Ensrud K, Bilezikian J, Rosen CJ. Hetereogeneity in skeletal response to full-length parathyroid hormone in the treatment of osteoporosis. Osteoporos Int. 2007 Jul;18(7):973-9. doi: 10.1007/s00198-007-0336-x. Epub 2007 Feb 28.
PubMed 17333451Antoniucci DM, Sellmeyer DE, Bilezikian JP, Palermo L, Ensrud KE, Greenspan SL, Black DM. Elevations in serum and urinary calcium with parathyroid hormone (1-84) with and without alendronate for osteoporosis. J Clin Endocrinol Metab. 2007 Mar;92(3):942-7. doi: 10.1210/jc.2006-1788. Epub 2006 Dec 12.
PubMed 17164314
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Parathyroid Hormone (PTH) and Alendronate in Combination in the Treatment of Osteoporosis
- ClinicalTrials.gov ID
- NCT00005005
- Acronym / sponsor ID
- N01 AR92245
- Conditions
- Osteoporosis
- Keywords
- PTH, Alendronate, Parathyroid hormone, Osteoporosis, Postmenopausal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Dennis BlackUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Oct 1999
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 27 Mar 2000 (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 2-year study will test the effectiveness of combining parathyroid hormone (PTH) and alendronate for treating osteoporosis in postmenopausal women. Alendronate is a drug used to treat osteoporosis and primarily prevents bone loss, whereas PTH increases bone formation. We will treat the study participants either with PTH and alendronate, alendronate alone, or PTH alone. We will determine the effects of these treatments by looking for changes in bone mineral density in the hip and spine.
Detailed description
The PaTH study is a 2-year, multicenter, double-blind, placebo-controlled trial to test the efficacy of combining hPTH (1-84) and alendronate for treating osteoporosis in postmenopausal women.
238 women were randomized between 55 and 85 years of age to receive either: (1) PTH for 1 year followed by alendronate for 1 year; (2) PTH and alendronate for 1 year followed by alendronate for 1 year; (3) alendronate for 2 years; or (4) PTH for 1 year followed by placebo for 1 year. The primary endpoints are changes in bone mineral density at several sites and changes in biochemical markers.
In addition, we will assess specific biochemical markers of bone turnover (e.g., osteocalcin, deoxypridinoline, N-telopeptide, bone-specific alkaline phosphatase and bone sialoprotein) to determine if they can predict the skeletal response to combination therapy. We will also determine whether PTH positively affects ultrasound measurements in the calcaneus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PTH, Drug: AlendronateParticipants will receive PTH for 1 year followed by alendronate for 1 year. |
| 2 | Experimental | Drug: PTH, Drug: AlendronateParticipants will receive PTH and alendronate for 1 year followed by alendronate for 1 year. |
| 3 | Experimental | Drug: AlendronateParticipants will receive alendronate for 2 years. |
| 4 | Active comparator | Drug: PTHParticipants will receive PTH for 1 year followed by placebo for 1 year. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 55 and 85 years
- Postmenopausal (have not had any menses in the last 5 years)
- Have a bone mineral density scan (DXA) that can be evaluated at the spine AND at the hip with a T-score equal to or below -2.5 at the spine or the femoral neck or total hip OR T-score equal to or below -2.0 at the spine or the femoral neck or total hip and have at least one of the following risk factors for fracture: (a) age > 65 years; (b) history of postmenopausal fracture (nonvertebral or vertebral); or (c) maternal history of hip fracture
- Willing and able to self-administer daily injections
Key exclusion criteria (25 listed)
- Have used estrogen (oral or patch) for more than 1 month in the last 6 months or more than 12 months in the last 2 years
- History of more than 12 months of bisphosphonate use ever, or any use (> 4 weeks) within the past 12 months
- History of rhPTH (recombinant human PTH) use
- Any major life-threatening illnesses
- Type 1 or uncontrolled type 2 diabetes mellitus (defined as hemoglobin A1C > 10.0), or currently using insulin
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 |
|---|---|---|
| PTH | Drug | 1, 2, 4 |
| Alendronate | Drug | 1, 2, 3 |
Primary outcome
Changes in bone mineral density at several sites and changes in biochemical markers
Time frame: Year 2
1 secondary outcome
Predictive value of specific biochemical markers of bone turnover
Time frame: Year 2
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 5 Feb 2013.
- Results publication: PubMed 14500804Black DM, Greenspan SL, Ensrud KE, Palermo L, McGowan JA, Lang TF, Garnero P, Bouxsein ML, Bilezikian JP, Rosen CJ; PaTH Study Investigators. The effects of parathyroid hormone and alendronate alone or in combination in postmenopausal osteoporosis. N Engl J Med. 2003 Sep 25;349(13):1207-15. doi: 10.1056/NEJMoa031975. Epub 2003 Sep 20.
- Results publication: PubMed 16093464Black DM, Bilezikian JP, Ensrud KE, Greenspan SL, Palermo L, Hue T, Lang TF, McGowan JA, Rosen CJ; PaTH Study Investigators. One year of alendronate after one year of parathyroid hormone (1-84) for osteoporosis. N Engl J Med. 2005 Aug 11;353(6):555-65. doi: 10.1056/NEJMoa050336.
- Results publication: PubMed 16449339Bauer DC, Garnero P, Bilezikian JP, Greenspan SL, Ensrud KE, Rosen CJ, Palermo L, Black DM. Short-term changes in bone turnover markers and bone mineral density response to parathyroid hormone in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2006 Apr;91(4):1370-5. doi: 10.1210/jc.2005-1712. Epub 2006 Jan 31.
- Results publication: PubMed 17333451Sellmeyer DE, Black DM, Palermo L, Greenspan S, Ensrud K, Bilezikian J, Rosen CJ. Hetereogeneity in skeletal response to full-length parathyroid hormone in the treatment of osteoporosis. Osteoporos Int. 2007 Jul;18(7):973-9. doi: 10.1007/s00198-007-0336-x. Epub 2007 Feb 28.
- Results publication: PubMed 17164314Antoniucci DM, Sellmeyer DE, Bilezikian JP, Palermo L, Ensrud KE, Greenspan SL, Black DM. Elevations in serum and urinary calcium with parathyroid hormone (1-84) with and without alendronate for osteoporosis. J Clin Endocrinol Metab. 2007 Mar;92(3):942-7. doi: 10.1210/jc.2006-1788. Epub 2006 Dec 12.
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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.
Dennis Black, PhD principal investigator
University of California, San Francisco
4 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 PTH and Alendronate in people with Osteoporosis, run by Dennis Black at 4 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 4 inclusion and 25 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 5 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
Changes in bone mineral density at several sites and changes in biochemical markers (time frame: Year 2). 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 NCT00005005, which also lists 5 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 5 Feb 2013.