The Effects of Ibandronate or Teriparatide Therapy on Bone Histology and Biochemical Indices in Patients on Hemodialysis With Low Bone Mineral Density
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| ClinicalTrials.gov Identifier: NCT00446589 |
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Recruitment Status
:
Terminated
(due to financial problems)
First Posted
: March 13, 2007
Last Update Posted
: October 29, 2014
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- Study Details
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Hemodialysis patients with low bone density (total hip T-score <-2.5) will be assigned to receive teriparatide (those with histologic confirmation of adynamic bone disease) or ibandronate (subjects with increased osteoclast number on bone biopsy).
Follow-up period: one year. A second bone biopsy at the end of the study.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteoporosis | Drug: ibandronate Drug: teriparatide | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 19 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Study Start Date : | July 2006 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: F
HD pts suffering from osteoporosis and adynamic bone disease who received teriparatide
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Drug: teriparatide
sc injection using a pen like device during every hemodialysis session (thrice a week)
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Experimental: I
Hemodialysis pts suffering from osteoporosis who received iv ibandronate
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Drug: ibandronate
iv 1mg ibandronate monthly for one year
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- Effects of ibandronate and teriparatide on bone mineral density and bone histology in HD patients. [ Time Frame: one year ]
- Effects of ibandronate and teriparatide on other bone disease markers [ Time Frame: one year ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Bone mineral density (T-score<-2.5)
- Adynamic bone disease for the teriparatide group
- Increased osteoclast number on bone biopsy (high turnover) for the ibandronate group
- Calcium greater than 8.1 mg/dl
Exclusion Criteria:
- Suspected carcinoma
- Unstable clinical setting
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00446589
| Greece | |
| Papageorgiou General Hospital | |
| Thessaloniki, Greece, 56403 | |
| Principal Investigator: | Efstathios Mitsopoulos, MD | Papageorgiou General Hospital, Thessaloniki, Greece |
| Responsible Party: | Efstathios Mitsopoulos, Nephrologist, Papageorgiou General Hospital |
| ClinicalTrials.gov Identifier: | NCT00446589 History of Changes |
| Other Study ID Numbers: |
47b/31-1-2005 |
| First Posted: | March 13, 2007 Key Record Dates |
| Last Update Posted: | October 29, 2014 |
| Last Verified: | October 2014 |
Additional relevant MeSH terms:
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Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases |
Ibandronic acid Teriparatide Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs |