OsteoporosisPhase 4NCT00221299
Risedronate and Parathyroid Hormone to Reverse Osteoporosis Caused by Chronic Steroid Use
A Phase 4 study testing Risedronate and Parathyroid Hormone in people with Osteoporosis, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of the study is to learn if one year of treatment with parathyroid hormone (PTH), either alone or with risedronate, will increase the thickness of the bones in the hip and spine in subjects with osteoporosis from chronic low dose steroid use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Risedronate and Parathyroid Hormone
- Type of treatment
- Pill or oral medicine, 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
- Sep 2005to May 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, greater than 18 years of age with a history of glucocorticoid therapy with prednisone ≥ 7.5mg/d for 6 months, and currently on prednisone ≥ 5mg /day.
- DXA of the lumbar spine (L1-L4) or total hip or femoral neck T score ≤ -1.5 with or without a prevalent vertebral fracture. (The T score is the number of standard deviations above or below the population mean for young, normal pre-menopausal females age 30).
- Investigators are satisfied that that there is no physical condition that would prevent a patient from receiving the proposed treatment regimens.
- Patient is ambulatory and able to return to the site of the investigation at specified time during the study.
- The patient is willing to participate in the proposed study as evidenced by signing an informed consent.
- Women of childbearing age are willing to use 2 forms of contraception during the entire study period.
- Have at least one analyzable BMD site: lumbar spine and/or proximal femur
Who cannot join
- Generalized disease of bone other than related to a rheumatic disease and glucocorticoid-induced osteoporosis including: hyperparathyroidism, hypoparathyroidism, Paget's disease of bone
- Diseases that may affect bone metabolism including: alcoholism, hyperthyroidism, renal impairment (creatinine > 2.5mg/dl) or hepatic impairment (SGOT levels > 2x upper limit of normal
- Urinary excretion of calcium > 400mg/day
- History of drug abuse
- Previous use of alendronate within 6 months prior to the study
- Previous use of risedronate, hormone replacement therapy or calcitonin within 2 months prior to the study
Show all 11Show fewer
- History of unstable cardiovascular disease or uncontrolled hypertension
- Severe scoliosis, greater than 2 lumbar fractures, or spinal surgery such that a precise bone mass measurement could be affected
- History of gastrointestinal intolerance to bisphosphonates
- History of cancer within 5 years of the study
- Patients on glucocorticoids for organ transplantation
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis General Medicine Research Clinic
Sacramento, California, 95817
About this study
Official title: Can Risedronate and Parathyroid Hormone Reverse Glucocorticoid Induced Osteoporosis?
The purpose of the study is to learn if one year of treatment with parathyroid hormone (PTH), either alone or with risedronate, will increase the thickness of the bones in the hip and spine in subjects with osteoporosis from chronic low dose steroid use. During the second year, the study will also look at whether taking risedronate will preserve the bone thickness created by one year of rhPTH 1-34 treatment.
Read the detailed description
Dr. Nancy Lane and colleagues at the University of California, Davis and University of California, San Francisco will be conducting this 2-year study of human parathyroid hormone (rhPTH 1-34) alone, and rhPTH (1-34) with risedronate compared to risedronate alone in men and women with osteopenia on chronic low dose glucocorticoids (GC). This is an investigator-initiated study funded by Aventis Pharmaceuticals.
The study will be divided into 2 phases. All study subjects will receive supplemental calcium citrate and Vitamin D during the 2-year study. In year one subjects will be randomly assigned to receive PTH (subcutaneously daily) or placebo and risedronate tablets or placebo. In year two, PTH will be stopped and subjects in group 1 will be re-randomized to receive risedronate tablets or placebo. Subjects in group 2 and 3 will continue on risedronate tablets.
In year one of the study, subjects were randomly assigned to one of the following treatment groups.
- Group 1: rhPTH (1-34) (20ug subcutaneously daily) + riesdronate placebo tablets
- Group 2: rhPTh (1-34) (20ug subcutaneously daily) + risedronate tablets (35mg/wk)
- Group 3: rhPTh placebo (subcutaneous injections of normal saline) + risedronate tablets (35mg/wk)
In year two of the study, beginning at the 12 month timepoint
- Group 1 subjects were re-randomized to either: Group 1a: risedronate (35mg/wk) or Group 1b: risedronate placebo
- Group 2 subjects continued risedronate (35mg/wk)
- Group 3 subjects continued risedronate (35mg/wk)
Potential study subjects will have dual x-ray absorptiometry measurements (DEXA) of the spine and hip at the screening visit. Those study subjects who meet the inclusion criteria will be invited back for a baseline visit.
DEXA scans of the spine, hip, and forearm will be done at Baseline visit, 6-month, 12-month, 18-month, and 24-month follow-up visits. DEXA scan of the spine, hip, and forearm takes approximately 20 minutes to complete. To assess incident vertebral and non-vertebral fractures, lateral thoracic and lumbar spine evaluation using Instant Vertebral Assessment [IVA] will be done at Baseline, 12-month, and 24-month follow-up visits.
The specific aims of the study are as follows:
- To determine if changes in bone mineral density in the spine and hip caused by 1 year of treatment with rhPTH (1-34) alone then followed by risedronate or rhPTH (1-34) with risedronate are greater than PTH placebo and risedronate in patients with GIO who are taking calcium, MVIs and chronic low doses of glucocorticoids.
- To determine if risedronate will preserve the high bone mass state created by 1 year of rhPTH (1-34) treatment.
- To determine the association of biochemical markers of bone turnover with rhPTH (1-34) and risedronate both during and after treatment.
- To compare, as possible, the fracture incidence between the rhPTH (1-34) alone followed by risedronate, and rhPTH (1-34) with risedronate compared to risedronate + placebo groups.
- Conditions
- Osteoporosis
- Being tested
- Risedronate, Parathyroid Hormone
- Keywords
- Osteoporosis, Steroids, Prednisone
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisedronateDrug
Also called Actonel, NDC# 0149-0472-04
One 35mg tab of risedronate/placebo taken once a week for one year.
Parathyroid HormoneDrug
Also called Forteo, PTH, rhPTH 1-34, NDC# 0002-8971-01
This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year.
| Study group | Role | What they receive |
|---|---|---|
| Group1a-rhPTH&RIS-Placebo(Y1)&RIS(Y2) | Active comparator | First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - re-randomized to risedronate (35mg/wk) tablets for second year. Receives: Drug: Risedronate; Drug: Parathyroid Hormone |
| Group1b-rhPTH&RisendronatePlacebo | Active comparator | First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - continue on risedronate placebo tablets for second year. Receives: Drug: Parathyroid Hormone |
| Group2-rhPTH&Risedronate | Active comparator | First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate tablets (35mg/wk) tablets for one year Second phase (year 2) - continue on risedronate tablets (35mg/wk) for second year. Receives: Drug: Risedronate; Drug: Parathyroid Hormone |
| Group3-rhPTH-Placebo&Risedronate | Active comparator | First phase (year 1) - parathyroid hormone (rhPTH 1-34), placebo SC injections of normal saline daily and risedronate tablets (35mg/wk) tablets for one year Second phase (year 2) - continue on risedronate tablets (35mg/wk) for second year. Receives: Drug: Risedronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density (BMD): Examine the Pattern and Effect of BMD Changes at Hip and Spine Measured by DXA Every 6 Months.
In this randomized clinical trial to determine if treatment with rhPTH (1-34) with and without risedronate will increase bone mass of the lumbar spine more than risedronate alone. This was a small pilot study and study subjects were recruited from two study sites. Our primary endpoint was change in lumbar spine BMD.
Measured: BMD changes from year 1 to year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionMar 2009
- Study completionMay 2009
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.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Principal investigator, Nancy E. Lane, MD, University of California, Davis
- Investigators
- Nancy E Lane, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221299
- Sponsor's protocol ID
- 200513216
- Status last verified
- Jun 2015
- First submitted
- 14 Sep 2005
- Last updated
- 25 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Risedronate and Parathyroid Hormone Reverse Glucocorticoid Induced Osteoporosis?
- ClinicalTrials.gov ID
- NCT00221299
- Acronym / sponsor ID
- 200513216
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, Steroids, Prednisone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- Sep 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 25 Jun 2015
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 the study is to learn if one year of treatment with parathyroid hormone (PTH), either alone or with risedronate, will increase the thickness of the bones in the hip and spine in subjects with osteoporosis from chronic low dose steroid use. During the second year, the study will also look at whether taking risedronate will preserve the bone thickness created by one year of rhPTH 1-34 treatment.
Detailed description
Dr. Nancy Lane and colleagues at the University of California, Davis and University of California, San Francisco will be conducting this 2-year study of human parathyroid hormone (rhPTH 1-34) alone, and rhPTH (1-34) with risedronate compared to risedronate alone in men and women with osteopenia on chronic low dose glucocorticoids (GC). This is an investigator-initiated study funded by Aventis Pharmaceuticals.
The study will be divided into 2 phases. All study subjects will receive supplemental calcium citrate and Vitamin D during the 2-year study. In year one subjects will be randomly assigned to receive PTH (subcutaneously daily) or placebo and risedronate tablets or placebo. In year two, PTH will be stopped and subjects in group 1 will be re-randomized to receive risedronate tablets or placebo. Subjects in group 2 and 3 will continue on risedronate tablets.
In year one of the study, subjects were randomly assigned to one of the following treatment groups.
- Group 1: rhPTH (1-34) (20ug subcutaneously daily) + riesdronate placebo tablets
- Group 2: rhPTh (1-34) (20ug subcutaneously daily) + risedronate tablets (35mg/wk)
- Group 3: rhPTh placebo (subcutaneous injections of normal saline) + risedronate tablets (35mg/wk)
In year two of the study, beginning at the 12 month timepoint
- Group 1 subjects were re-randomized to either: Group 1a: risedronate (35mg/wk) or Group 1b: risedronate placebo
- Group 2 subjects continued risedronate (35mg/wk)
- Group 3 subjects continued risedronate (35mg/wk)
Potential study subjects will have dual x-ray absorptiometry measurements (DEXA) of the spine and hip at the screening visit. Those study subjects who meet the inclusion criteria will be invited back for a baseline visit.
DEXA scans of the spine, hip, and forearm will be done at Baseline visit, 6-month, 12-month, 18-month, and 24-month follow-up visits. DEXA scan of the spine, hip, and forearm takes approximately 20 minutes to complete. To assess incident vertebral and non-vertebral fractures, lateral thoracic and lumbar spine evaluation using Instant Vertebral Assessment [IVA] will be done at Baseline, 12-month, and 24-month follow-up visits.
The specific aims of the study are as follows:
- To determine if changes in bone mineral density in the spine and hip caused by 1 year of treatment with rhPTH (1-34) alone then followed by risedronate or rhPTH (1-34) with risedronate are greater than PTH placebo and risedronate in patients with GIO who are taking calcium, MVIs and chronic low doses of glucocorticoids.
- To determine if risedronate will preserve the high bone mass state created by 1 year of rhPTH (1-34) treatment.
- To determine the association of biochemical markers of bone turnover with rhPTH (1-34) and risedronate both during and after treatment.
- To compare, as possible, the fracture incidence between the rhPTH (1-34) alone followed by risedronate, and rhPTH (1-34) with risedronate compared to risedronate + placebo groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group1a-rhPTH&RIS-Placebo(Y1)&RIS(Y2) | Active comparator | Drug: Risedronate, Drug: Parathyroid HormoneFirst phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - re-randomized to risedronate (35mg/wk) tablets for second year. |
| Group1b-rhPTH&RisendronatePlacebo | Active comparator | Drug: Parathyroid HormoneFirst phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - continue on risedronate placebo tablets for second year. |
| Group2-rhPTH&Risedronate | Active comparator | Drug: Risedronate, Drug: Parathyroid HormoneFirst phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate tablets (35mg/wk) tablets for one year Second phase (year 2) - continue on risedronate tablets (35mg/wk) for second year. |
| Group3-rhPTH-Placebo&Risedronate | Active comparator | Drug: RisedronateFirst phase (year 1) - parathyroid hormone (rhPTH 1-34), placebo SC injections of normal saline daily and risedronate tablets (35mg/wk) tablets for one year Second phase (year 2) - continue on risedronate tablets (35mg/wk) for second year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women, greater than 18 years of age with a history of glucocorticoid therapy with prednisone ≥ 7.5mg/d for 6 months, and currently on prednisone ≥ 5mg /day.
- DXA of the lumbar spine (L1-L4) or total hip or femoral neck T score ≤ -1.5 with or without a prevalent vertebral fracture. (The T score is the number of standard deviations above or below the population mean for young, normal pre-menopausal females age 30).
- Investigators are satisfied that that there is no physical condition that would prevent a patient from receiving the proposed treatment regimens.
- Patient is ambulatory and able to return to the site of the investigation at specified time during the study.
- The patient is willing to participate in the proposed study as evidenced by signing an informed consent.
Key exclusion criteria (11 listed)
- Generalized disease of bone other than related to a rheumatic disease and glucocorticoid-induced osteoporosis including: hyperparathyroidism, hypoparathyroidism, Paget's disease of bone
- Diseases that may affect bone metabolism including: alcoholism, hyperthyroidism, renal impairment (creatinine > 2.5mg/dl) or hepatic impairment (SGOT levels > 2x upper limit of normal
- Urinary excretion of calcium > 400mg/day
- History of drug abuse
- Previous use of alendronate within 6 months prior to the study
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 |
|---|---|---|
| RisedronateAlso: Actonel, NDC# 0149-0472-04One 35mg tab of risedronate/placebo taken once a week for one year. | Drug | Group1a-rhPTH&RIS-Placebo(Y1)&RIS(Y2), Group2-rhPTH&Risedronate, Group3-rhPTH-Placebo&Risedronate |
| Parathyroid HormoneAlso: Forteo, PTH, rhPTH 1-34, NDC# 0002-8971-01This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year. | Drug | Group1a-rhPTH&RIS-Placebo(Y1)&RIS(Y2), Group1b-rhPTH&RisendronatePlacebo, Group2-rhPTH&Risedronate |
Primary outcome
Bone Mineral Density (BMD): Examine the Pattern and Effect of BMD Changes at Hip and Spine Measured by DXA Every 6 Months.
Time frame: BMD changes from year 1 to year 2
In this randomized clinical trial to determine if treatment with rhPTH (1-34) with and without risedronate will increase bone mass of the lumbar spine more than risedronate alone. This was a small pilot study and study subjects were recruited from two study sites. Our primary endpoint was change in lumbar spine BMD.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nancy E Lane, MD principal investigator
University of California, Davis
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 Risedronate and Parathyroid Hormone in people with Osteoporosis, run by University of California, Davis 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 7 inclusion and 11 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 25 Jun 2015. 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 25 Jun 2015). 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 Mineral Density (BMD): Examine the Pattern and Effect of BMD Changes at Hip and Spine Measured by DXA Every 6 Months. (time frame: BMD changes from year 1 to year 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2015.