Weekly vs Daily Teriparatide Therapy in Severe Postmenopausal Osteoporosis

April 15, 2014 updated by: Sanjay K. Bhadada, Postgraduate Institute of Medical Education and Research

To Compare Efficacy of Weekly Versus Daily Teriparatide in the Management of Postmenopausal Osteoporosis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • UT
      • Chandigarh, UT, India, 1600012
        • Recruiting
        • PGIMER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
6 week, 6 month and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ANTICIPATED)

June 1, 2014

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

January 2, 2013

First Submitted That Met QC Criteria

January 3, 2013

First Posted (ESTIMATE)

January 4, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 16, 2014

Last Update Submitted That Met QC Criteria

April 15, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • teriparatide

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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