Weekly vs Daily Teriparatide Therapy in Severe Postmenopausal Osteoporosis

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01760798
• Other study ID #: teriparatide
• Status: Recruiting
• Phase: N/A
• First received: January 2, 2013
• Last updated: April 15, 2014
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: April 2014
• Source: Postgraduate Institute of Medical Education and Research
• Contact: Sanjay Kr Bhadada, DM
• Email: bhadadask[@]rediffmail.com
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• Teriparatide

Locations

Country	Name	City	State
India	PGIMER	Chandigarh	UT

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMD at Hip and lumber spine	DEXA scan(BMD at hip and lumbar spine) at baseline and at the end of 1 year	1 year	Yes
Primary	Reduction in fracture risk	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	Yes