Rheumatoid ArthritisPhase 3NCT00138983
Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol.
A Phase 3 study testing Alendronate versus alfacalcidol (1-alpha OH vitamin D) in people with Rheumatoid Arthritis and Polymyalgia Rheumatica, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine wich treatment is the most effective in prevention of glucocorticoid-induced osteoporosis in patients with rheumatic diseases. The STOP-study: a randomized placebo controlled trial with alendronate versus alfacalcidol. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rheumatoid Arthritis, Polymyalgia Rheumatica, Giant Cell Arteritis
- What is being tested?
- Alendronate versus alfacalcidol (1-alpha OH vitamin D)
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2000to Nov 2003
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a rheumatic disease.
- Starting treatment with glucocorticoids in a dosage of 7.5 mg prednisone equivalent daily or higher.
- All ethnic groups and races.
Who cannot join
- Glucocorticoid treatment in the past 12 months (except for 12 weeks preceding the study)
- Primary hyperparathyroidism, hyperthyroidism or hypothyroidism in last year
- Metabolic bone disease
- Creatinine clearance of < 50 ml/min
- Documented hypercalcemia or hypercalciuria, nephrolithiasis in the last 5 years
- Pregnancy or lactation
- Treatment in the last 12 months with hormone-replacement therapy
- Anabolic steroids, calcitonin, active vitamin D3 analogues, fluoride or bisphosphonates.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol.
The purpose of this study is to determine wich treatment is the most effective in prevention of glucocorticoid-induced osteoporosis in patients with rheumatic diseases. The STOP-study: a randomized placebo controlled trial with alendronate versus alfacalcidol.
Read the detailed description
Treatment with glucocorticoids (GCs) is associated with bone loss initiated already early in therapy, causing increased (vertebral) fracture risk. Bone loss is caused by inhibition of bone formation by GCs. Active vitamin D analogues like alfacalcidol directly stimulate osteoblasts leading to an increase in bone formation. Bisphosphonates like alendronate induce apoptosis of osteoclasts leading to inhibition of bone resorption.
We performed a randomized, double-placebo, double-blind clinical trial of 18 months duration in patients with a rheumatic disease, starting GCs in a dosage of 7.5 mg prednisone equivalent daily or higher. Two hundred one patients were allocated to receive either alendronate 10 mg and alfacalcidol-placebo daily or alfacalcidol 1 microgram and alendronate-placebo daily. Primary outcome was change in bone mineral density of the lumbar spine in 18 months, secondary outcome incidence of (symptomatic) morphometric vertebral deformities.
- Conditions
- Rheumatoid Arthritis, Polymyalgia Rheumatica, Giant Cell Arteritis, Polymyositis, Wegener's Granulomatosis
- Being tested
- Alendronate versus alfacalcidol (1-alpha OH vitamin D)
- Keywords
- glucocorticoid-induced osteoporosis, rheumatic diseases, prevention, randomized double-blind, double placebo controlled trial, alendronate versus alfacalcidol
- Medical subject headings
- Arthritis, Rheumatoid, Polymyalgia Rheumatica, Giant Cell Arteritis, Polymyositis, Granulomatosis with Polyangiitis, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alendronate versus alfacalcidol (1-alpha OH vitamin D)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in bone mineral density of the lumbar spine (lumbar vertebrae 2 to 4) at 18 months.
Secondary outcomes (1)
Percent change in bone mineral density of the femoral neck and total hip at 18 months and incidence of morphometrical vertebral deformities, symptomatic vertebral fractures and non-vertebral fractures.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startMay 2000
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Health Care Insurance Board
- Investigators
- J.W.J. Bijslma, Prof., Principal investigator, UMC UtrechtR.N.J.T.L. de Nijs, MD, Study director, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138983
- Sponsor's protocol ID
- OG67-STOP-study
- Status last verified
- Mar 2000
- First submitted
- 29 Aug 2005
- Last updated
- 29 Nov 2006
- Results posted
- No
Publications
Lukert BP, Raisz LG. Glucocorticoid-induced osteoporosis: pathogenesis and management. Ann Intern Med. 1990 Mar 1;112(5):352-64. doi: 10.7326/0003-4819-112-5-352.
PubMed 2407167de Nijs RN, Jacobs JW, Algra A, Lems WF, Bijlsma JW. Prevention and treatment of glucocorticoid-induced osteoporosis with active vitamin D3 analogues: a review with meta-analysis of randomized controlled trials including organ transplantation studies. Osteoporos Int. 2004 Aug;15(8):589-602. doi: 10.1007/s00198-004-1614-5. Epub 2004 May 7.
PubMed 15138667Saag KG, Emkey R, Schnitzer TJ, Brown JP, Hawkins F, Goemaere S, Thamsborg G, Liberman UA, Delmas PD, Malice MP, Czachur M, Daifotis AG. Alendronate for the prevention and treatment of glucocorticoid-induced osteoporosis. Glucocorticoid-Induced Osteoporosis Intervention Study Group. N Engl J Med. 1998 Jul 30;339(5):292-9. doi: 10.1056/NEJM199807303390502.
PubMed 9682041de Nijs RN, Jacobs JW, Lems WF, Laan RF, Algra A, Huisman AM, Buskens E, de Laet CE, Oostveen AC, Geusens PP, Bruyn GA, Dijkmans BA, Bijlsma JW; STOP Investigators. Alendronate or alfacalcidol in glucocorticoid-induced osteoporosis. N Engl J Med. 2006 Aug 17;355(7):675-84. doi: 10.1056/NEJMoa053569.
PubMed 16914703de Nijs RN, Jacobs JW, Lems WF, Laan RF, Algra A, Huisman AM, Buskens E, de Laet CE, Oostveen JC, Geusens PP, Bruyn GA, Dijkmans BA, Bijlsmat JW. [Alendronate more effective than alfacalcidol in the prevention of osteoporosis in patients with rheumatic disease who are starting glucocorticoid therapy]. Ned Tijdschr Geneeskd. 2007 May 26;151(21):1178-85. Dutch.
PubMed 17557758Jacobs JW, de Nijs RN, Lems WF, Geusens PP, Laan RF, Huisman AM, Algra A, Buskens E, Hofbauer LC, Oostveen AC, Bruyn GA, Dijkmans BA, Bijlsma JW. Prevention of glucocorticoid induced osteoporosis with alendronate or alfacalcidol: relations of change in bone mineral density, bone markers, and calcium homeostasis. J Rheumatol. 2007 May;34(5):1051-7. Epub 2007 Apr 1.
PubMed 17407214
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol.
- ClinicalTrials.gov ID
- NCT00138983
- Acronym / sponsor ID
- OG67-STOP-study
- Conditions
- Rheumatoid Arthritis, Polymyalgia Rheumatica, Giant Cell Arteritis, Polymyositis, Wegener's Granulomatosis
- Keywords
- glucocorticoid-induced osteoporosis, rheumatic diseases, prevention, randomized double-blind, double placebo controlled trial, alendronate versus alfacalcidol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Dutch Health Care Insurance Board
- Study start
- May 2000
- Study completion
- Nov 2003
- First posted
- 30 Aug 2005 (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 wich treatment is the most effective in prevention of glucocorticoid-induced osteoporosis in patients with rheumatic diseases. The STOP-study: a randomized placebo controlled trial with alendronate versus alfacalcidol.
Detailed description
Treatment with glucocorticoids (GCs) is associated with bone loss initiated already early in therapy, causing increased (vertebral) fracture risk. Bone loss is caused by inhibition of bone formation by GCs. Active vitamin D analogues like alfacalcidol directly stimulate osteoblasts leading to an increase in bone formation. Bisphosphonates like alendronate induce apoptosis of osteoclasts leading to inhibition of bone resorption.
We performed a randomized, double-placebo, double-blind clinical trial of 18 months duration in patients with a rheumatic disease, starting GCs in a dosage of 7.5 mg prednisone equivalent daily or higher. Two hundred one patients were allocated to receive either alendronate 10 mg and alfacalcidol-placebo daily or alfacalcidol 1 microgram and alendronate-placebo daily. Primary outcome was change in bone mineral density of the lumbar spine in 18 months, secondary outcome incidence of (symptomatic) morphometric vertebral deformities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a rheumatic disease.
- Starting treatment with glucocorticoids in a dosage of 7.5 mg prednisone equivalent daily or higher.
- All ethnic groups and races.
Key exclusion criteria (8 listed)
- Glucocorticoid treatment in the past 12 months (except for 12 weeks preceding the study)
- Primary hyperparathyroidism, hyperthyroidism or hypothyroidism in last year
- Metabolic bone disease
- Creatinine clearance of < 50 ml/min
- Documented hypercalcemia or hypercalciuria, nephrolithiasis in the last 5 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 |
|---|---|---|
| Alendronate versus alfacalcidol (1-alpha OH vitamin D) | Drug | – |
Primary outcome
Percent change in bone mineral density of the lumbar spine (lumbar vertebrae 2 to 4) at 18 months.
1 secondary outcome
Percent change in bone mineral density of the femoral neck and total hip at 18 months and incidence of morphometrical vertebral deformities, symptomatic vertebral fractures and non-vertebral fractures.
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 29 Nov 2006.
- Background: PubMed 2407167Lukert BP, Raisz LG. Glucocorticoid-induced osteoporosis: pathogenesis and management. Ann Intern Med. 1990 Mar 1;112(5):352-64. doi: 10.7326/0003-4819-112-5-352.
- Background: PubMed 15138667de Nijs RN, Jacobs JW, Algra A, Lems WF, Bijlsma JW. Prevention and treatment of glucocorticoid-induced osteoporosis with active vitamin D3 analogues: a review with meta-analysis of randomized controlled trials including organ transplantation studies. Osteoporos Int. 2004 Aug;15(8):589-602. doi: 10.1007/s00198-004-1614-5. Epub 2004 May 7.
- Background: PubMed 9682041Saag KG, Emkey R, Schnitzer TJ, Brown JP, Hawkins F, Goemaere S, Thamsborg G, Liberman UA, Delmas PD, Malice MP, Czachur M, Daifotis AG. Alendronate for the prevention and treatment of glucocorticoid-induced osteoporosis. Glucocorticoid-Induced Osteoporosis Intervention Study Group. N Engl J Med. 1998 Jul 30;339(5):292-9. doi: 10.1056/NEJM199807303390502.
- Results publication: PubMed 16914703de Nijs RN, Jacobs JW, Lems WF, Laan RF, Algra A, Huisman AM, Buskens E, de Laet CE, Oostveen AC, Geusens PP, Bruyn GA, Dijkmans BA, Bijlsma JW; STOP Investigators. Alendronate or alfacalcidol in glucocorticoid-induced osteoporosis. N Engl J Med. 2006 Aug 17;355(7):675-84. doi: 10.1056/NEJMoa053569.
- Derived from this study: PubMed 17557758de Nijs RN, Jacobs JW, Lems WF, Laan RF, Algra A, Huisman AM, Buskens E, de Laet CE, Oostveen JC, Geusens PP, Bruyn GA, Dijkmans BA, Bijlsmat JW. [Alendronate more effective than alfacalcidol in the prevention of osteoporosis in patients with rheumatic disease who are starting glucocorticoid therapy]. Ned Tijdschr Geneeskd. 2007 May 26;151(21):1178-85. Dutch.
- Derived from this study: PubMed 17407214Jacobs JW, de Nijs RN, Lems WF, Geusens PP, Laan RF, Huisman AM, Algra A, Buskens E, Hofbauer LC, Oostveen AC, Bruyn GA, Dijkmans BA, Bijlsma JW. Prevention of glucocorticoid induced osteoporosis with alendronate or alfacalcidol: relations of change in bone mineral density, bone markers, and calcium homeostasis. J Rheumatol. 2007 May;34(5):1051-7. Epub 2007 Apr 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.
J.W.J. Bijslma, Prof. principal investigator
UMC Utrecht
R.N.J.T.L. de Nijs, MD study director
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alendronate versus alfacalcidol (1-alpha OH vitamin D) in people with Rheumatoid Arthritis and Polymyalgia Rheumatica, run by UMC Utrecht at 1 site in Netherlands.
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 3 inclusion and 8 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 29 Nov 2006. 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 Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percent change in bone mineral density of the lumbar spine (lumbar vertebrae 2 to 4) at 18 months.. 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 NCT00138983, 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 29 Nov 2006.