Trial record 2 of 201 for:    Open Studies | "Osteoporosis"

Weekly vs Daily Teriparatide Therapy in Severe Postmenopausal Osteoporosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Postgraduate Institute of Medical Education and Research
Sponsor:
Information provided by (Responsible Party):
Sanjay K. Bhadada, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01760798
First received: January 2, 2013
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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 Intervention
Osteoporosis
Drug: Teriparatide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: To Compare Efficacy of Weekly Versus Daily Teriparatide in the Management of Postmenopausal Osteoporosis

Resource links provided by NLM:


Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • BMD at Hip and lumber spine [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Reduction in fracture risk using online FRAX tool( WHO fracture risk assessment tool) at baseline and at 1year


Estimated Enrollment: 20
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Daily Teriparatide group
This group will recieve 20µg of teriparatide by subcutaneous route daily at 8 pm for 1 year
Drug: Teriparatide
Experimental: Weekly Teriparatide group
This group will recieve 60µg of teriparatide by subcutaneous route weekly at 8pm on Sunday for 1 year
Drug: Teriparatide

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01760798

Contacts
Contact: Sanjay Kr Bhadada, DM bhadadask@rediffmail.com
Contact: Vipin Gupta, MBBS drvipin.gupta@yahoo.com

Locations
India
PGIMER Recruiting
Chandigarh, UT, India, 1600012
Contact: Sanjay Kr Bhadada, DM       bhadadask@rediffmail.com   
Principal Investigator: Sanjay Kr Bhadada, DM         
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Sanjay Kr Bhadada, DM Associate Professor, Department of Endocrinology, PGIMER Chandigarh India
  More Information

No publications provided

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
Study First Received: January 2, 2013
Last Updated: April 15, 2014
Health Authority: India: Indian Council of Medical Research

Keywords provided by Postgraduate Institute of Medical Education and Research:
osteoporosis
Teriparatide

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014