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Weekly vs Daily Teriparatide Therapy in Severe Postmenopausal Osteoporosis

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ClinicalTrials.gov Identifier: NCT01760798
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
Sponsor:
Information provided by (Responsible Party):
Sanjay K. Bhadada, Postgraduate Institute of Medical Education and Research

Tracking Information
First Submitted Date  ICMJE January 2, 2013
First Posted Date  ICMJE January 4, 2013
Last Update Posted Date April 16, 2014
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01760798 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Weekly vs Daily Teriparatide Therapy in Severe Postmenopausal Osteoporosis
Official Title  ICMJE To Compare Efficacy of Weekly Versus Daily Teriparatide in the Management of Postmenopausal Osteoporosis
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoporosis
Intervention  ICMJE Drug: Teriparatide
Study Arms  ICMJE
  • Active Comparator: Daily Teriparatide group
    This group will recieve 20µg of teriparatide by subcutaneous route daily at 8 pm for 1 year
    Intervention: Drug: Teriparatide
  • Experimental: Weekly Teriparatide group
    This group will recieve 60µg of teriparatide by subcutaneous route weekly at 8pm on Sunday for 1 year
    Intervention: Drug: Teriparatide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 3, 2013)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01760798
Other Study ID Numbers  ICMJE teriparatide
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanjay K. Bhadada, Postgraduate Institute of Medical Education and Research
Study Sponsor  ICMJE Postgraduate Institute of Medical Education and Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sanjay Kr Bhadada, DM Associate Professor, Department of Endocrinology, PGIMER Chandigarh India
PRS Account Postgraduate Institute of Medical Education and Research
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP