OsteoporosisNCT00572299
Glucocorticoids Promote Osteoclast Survival
An observational study of Osteoporosis, run by University of Arkansas at 1 site in United States.
Trial summary
The purpose of this study is to determine the difference in response to bisphosphonate therapy in patients receiving excess glucocorticoids compared to patients with postmenopausal or male osteoporosis. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- alendronate
- Type of treatment
- Pill or oral medicine
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to May 2010
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: adults receiving aminobisphosphonate therapy to prevent osteoporosis from glucocorticoids, postmenopausal bone loss or osteoporosis in males
Who may be able to join
- 18 years old or greater
- agree to at least one bone biopsy
- agree to BMD, blood and urine tests
- receiving at least 10 mg/day of prednisone for at least three months
- either be a candidate for alendronate or be taking alendronate (70 mg/week for at least three months)
Who cannot join
- any metabolic bone disorder such as Paget's disease, renal osteodystrophy, parathyroid disease or osteomalacia
- obesity enough to make a biopsy difficult
- concurrent use of any tetracycline
- hypercalcemia
- kidney stones in the last two years
- home O2
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- gastric surgery, stapling or bypass
- inflammatory bowel disease
- untreated thyroid disease
- organ transplants
- malabsorption
- anticoagulation
- current infection
- serious illness
- allergy to Demerol, Valium, iodine, tetracycline, tape
- use of anticonvulsant drugs, heparin, Forteo, calcitonin or high-dose fluoride within the past six months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas hospitals and clinics and the Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205
About this study
The purpose of this study is to determine the difference in response to bisphosphonate therapy in patients receiving excess glucocorticoids compared to patients with postmenopausal or male osteoporosis. Bisphosphonates are approved by the FDA for the treatment of postmenopausal women and osteoporotic men who are at high risk of fracture and in men and women with excess glucocorticoid administration.
Read the detailed description
Aminobisphosphonates are extensively used to prevent fractures in patients with osteoporosis (1-6). Treatment with these drugs leads to decreases in bone resorption and biochemical markers of bone turnover and progressive increases in bone mineral density (BMD). The increase in BMD in response to bisphosphonate therapy in glucocorticoid-treated patients is, however, less than half that measured in women and men with osteoporosis unrelated to glucocorticoid drugs even though the patients with osteoporosis are usually older. The goal of this objective is to determine the contribution of increased osteoclast survival to the diminished response to bisphosphonate therapy in patients receiving excess glucocorticoids compared to patients with osteoporosis.
- Liberman U, Weiss SR, Broll J, et al. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. N Engl J Med 1995;333:1437-1443.
- Bone HG, Downs RW, Tucci JR, et al. Dose-response relationships for alendronate treatment in osteoporotic elderly women. J Clin Endocrinol Metab 1997;82:265-274.
- McClung M, Clemmesen B, Daifotis A, et al. Alendronate prevents postmenopausal bone loss in women without osteoporosis. Ann Intern Med 1998;128:253-261.
- Recker RR, Weinstein RS, Chestnut CH III, et al. Histomorphometric evaluation of daily and intermittent oral ibandronate in women with postmenopausal osteoporosis: results from the BONE study. Osteoporosis Int 2004;15:231-237.
- Saag KG, Emkey R, Schnitzer TJ, et al. Alendronate for the prevention and treatment of glucocorticoid-induced osteoporosis. Glucocorticoid-Induced Osteoporosis Intervention Study Group. N Engl J Med 1998;339:292-299.
- Orwoll E, Ettinger M, Weiss S, et al. Alendronate for the treatment of osteoporosis in men. N Engl J Med 2000;343:604-610.
- Conditions
- Osteoporosis
- Being tested
- alendronate
- Keywords
- glucocorticoids, prednisone, alendronate,osteoclasts
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alendronateDrug
Also called Fosamax, Prednisone
70 mg of alendronate orally per week for at least three months in patients receiving at least 10 mg/day or oral prednisone for at least three months
| Study group | Role | What they receive |
|---|---|---|
| glucocorticoids | patients receiving glucocorticoid treatment | |
| glucocorticoids and bisphosphonates | patients receiving both glucocorticoids and bisphosphonates Receives: Drug: alendronate |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study startJan 2004
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: Terminated due to recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jimmie L Valentine, Study chair, IRB at UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572299
- Sponsor's protocol ID
- 28727
- Other IDs
- VA Merit Review Grant
- Status last verified
- Aug 2011
- First submitted
- 11 Dec 2007
- Last updated
- 30 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucocorticoids Promote Osteoclast Survival
- ClinicalTrials.gov ID
- NCT00572299
- Acronym / sponsor ID
- 28727
- Conditions
- Osteoporosis
- Keywords
- glucocorticoids, prednisone, alendronate,osteoclasts
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated due to recruitment problems
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 13 Dec 2007 (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.
The purpose of this study is to determine the difference in response to bisphosphonate therapy in patients receiving excess glucocorticoids compared to patients with postmenopausal or male osteoporosis. Bisphosphonates are approved by the FDA for the treatment of postmenopausal women and osteoporotic men who are at high risk of fracture and in men and women with excess glucocorticoid administration.
Detailed description
Aminobisphosphonates are extensively used to prevent fractures in patients with osteoporosis (1-6). Treatment with these drugs leads to decreases in bone resorption and biochemical markers of bone turnover and progressive increases in bone mineral density (BMD). The increase in BMD in response to bisphosphonate therapy in glucocorticoid-treated patients is, however, less than half that measured in women and men with osteoporosis unrelated to glucocorticoid drugs even though the patients with osteoporosis are usually older. The goal of this objective is to determine the contribution of increased osteoclast survival to the diminished response to bisphosphonate therapy in patients receiving excess glucocorticoids compared to patients with osteoporosis.
- Liberman U, Weiss SR, Broll J, et al. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. N Engl J Med 1995;333:1437-1443.
- Bone HG, Downs RW, Tucci JR, et al. Dose-response relationships for alendronate treatment in osteoporotic elderly women. J Clin Endocrinol Metab 1997;82:265-274.
- McClung M, Clemmesen B, Daifotis A, et al. Alendronate prevents postmenopausal bone loss in women without osteoporosis. Ann Intern Med 1998;128:253-261.
- Recker RR, Weinstein RS, Chestnut CH III, et al. Histomorphometric evaluation of daily and intermittent oral ibandronate in women with postmenopausal osteoporosis: results from the BONE study. Osteoporosis Int 2004;15:231-237.
- Saag KG, Emkey R, Schnitzer TJ, et al. Alendronate for the prevention and treatment of glucocorticoid-induced osteoporosis. Glucocorticoid-Induced Osteoporosis Intervention Study Group. N Engl J Med 1998;339:292-299.
- Orwoll E, Ettinger M, Weiss S, et al. Alendronate for the treatment of osteoporosis in men. N Engl J Med 2000;343:604-610.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glucocorticoids | – | –patients receiving glucocorticoid treatment |
| glucocorticoids and bisphosphonates | – | Drug: alendronatepatients receiving both glucocorticoids and bisphosphonates |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adults receiving aminobisphosphonate therapy to prevent osteoporosis from glucocorticoids, postmenopausal bone loss or osteoporosis in males
Key inclusion criteria (5 listed)
- 18 years old or greater
- agree to at least one bone biopsy
- agree to BMD, blood and urine tests
- receiving at least 10 mg/day of prednisone for at least three months
- either be a candidate for alendronate or be taking alendronate (70 mg/week for at least three months)
Key exclusion criteria (16 listed)
- any metabolic bone disorder such as Paget's disease, renal osteodystrophy, parathyroid disease or osteomalacia
- obesity enough to make a biopsy difficult
- concurrent use of any tetracycline
- hypercalcemia
- kidney stones in the last two years
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 |
|---|---|---|
| alendronateAlso: Fosamax, Prednisone70 mg of alendronate orally per week for at least three months in patients receiving at least 10 mg/day or oral prednisone for at least three months | Drug | glucocorticoids and bisphosphonates |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Terminated due to recruitment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2011.
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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.
Jimmie L Valentine study chair
IRB at UAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by University of Arkansas 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 5 inclusion and 16 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: stopped early, as of the sponsor's last update on 30 Aug 2011. 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.
Are results available for this study?
The study was stopped early (reason given: Terminated due to recruitment problems). Results are not available in the source record.
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.
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 30 Aug 2011.