Weekly vs Daily Teriparatide Therapy in Severe Postmenopausal Osteoporosis
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| ClinicalTrials.gov Identifier: NCT01760798 |
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Recruitment Status : Unknown
Verified April 2014 by Sanjay K. Bhadada, Postgraduate Institute of Medical Education and Research.
Recruitment status was: Recruiting
First Posted : January 4, 2013
Last Update Posted : April 16, 2014
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Osteoporosis is characterized by decreased bone strength and it is prevalent among postmenopausal women but also occurs in men and women with underlying conditions or major risk factors associated with bone demineralization. Its chief clinical manifestations are vertebral and hip fractures, although fractures can occur at any skeletal site.The World Health Organization (WHO) operationally defines osteoporosis as a bone density that falls 2.5 standard deviations (SD) below the mean for young healthy adults of the same gender—also referred to as T-score of -2.5. Postmenopausal women who fall at the lower end of the young normal range (a T-score of >1 SD below the mean) are defined as having low bone density (osteopenia) and are also at increased risk of osteoporosis. More than 50% of the fractures, including hip fractures, among postmenopausal women occur in this group.
Teriparatide is one of the most effective treatment options for osteoporosis. But the cost of teriparatide is prohibitively expensive and in countries like India with limited personal resources of the individuals, its not a feasible option in the majority of the patients with severe osteoporosis. The investigators aim to compare weekly versus daily teriparatide therapy in an open label non inferiority trial and if successful, the investigators anticipate, the cost of treatment could be reduced considerably so that treatment becomes more affordable to a larger number of patients. Also with weekly therapy, number of multiple injections could be brought down.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteoporosis | Drug: Teriparatide | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | To Compare Efficacy of Weekly Versus Daily Teriparatide in the Management of Postmenopausal Osteoporosis |
| Study Start Date : | January 2012 |
| Estimated Primary Completion Date : | June 2014 |
| Estimated Study Completion Date : | December 2014 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Daily Teriparatide group
This group will recieve 20µg of teriparatide by subcutaneous route daily at 8 pm for 1 year
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Drug: Teriparatide |
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Experimental: Weekly Teriparatide group
This group will recieve 60µg of teriparatide by subcutaneous route weekly at 8pm on Sunday for 1 year
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Drug: Teriparatide |
- BMD at Hip and lumber spine [ Time Frame: 1 year ]DEXA scan(BMD at hip and lumbar spine) at baseline and at the end of 1 year
- Reduction in fracture risk [ Time Frame: 6 week, 6 month and 1 year ]Reduction in fracture risk using online FRAX tool( WHO fracture risk assessment tool) at baseline and at 1year
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| Ages Eligible for Study: | 50 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Postmenopausal women of age group 50-70 having T score less than -2.5 SD or lower at lumbar spine or proximal femur.
Exclusion Criteria:
- Patients with renal dysfunction (serum creatinine >1.5)
- Primary and secondary hyperparathyroidism
- Secondary osteoporosis
- Unexplained elevated ALP (alkaline phosphatase)
- History of therapeutic radiation
- Active malignancy and patients having implant
- Patients who have received i.v. or oral bisphosphonates in their disease course
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): NCT01760798
| Contact: Sanjay Kr Bhadada, DM | bhadadask@rediffmail.com | ||
| Contact: Vipin Gupta, MBBS | drvipin.gupta@yahoo.com |
| India | |
| PGIMER | Recruiting |
| Chandigarh, UT, India, 1600012 | |
| Contact: Sanjay Kr Bhadada, DM bhadadask@rediffmail.com | |
| Principal Investigator: Sanjay Kr Bhadada, DM | |
| Principal Investigator: | Sanjay Kr Bhadada, DM | Associate Professor, Department of Endocrinology, PGIMER Chandigarh India |
| Responsible Party: | Sanjay K. Bhadada, Associate Professor, Dept of Endocrinology, Postgraduate Institute of Medical Education and Research |
| ClinicalTrials.gov Identifier: | NCT01760798 History of Changes |
| Other Study ID Numbers: |
teriparatide |
| First Posted: | January 4, 2013 Key Record Dates |
| Last Update Posted: | April 16, 2014 |
| Last Verified: | April 2014 |
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osteoporosis Teriparatide |
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Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
Metabolic Diseases Teriparatide Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Bone Density Conservation Agents |