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Weekly vs Daily Teriparatide Therapy in Severe Postmenopausal Osteoporosis

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01760798
Enrollment
20
Registered
2013-01-04
Start date
2012-01-31
Completion date
2014-12-31
Last updated
2014-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

osteoporosis, Teriparatide

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.

Interventions

DRUGTeriparatide

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frameDescription
BMD at Hip and lumber spine1 yearDEXA scan(BMD at hip and lumbar spine) at baseline and at the end of 1 year
Reduction in fracture risk6 week, 6 month and 1 yearReduction in fracture risk using online FRAX tool( WHO fracture risk assessment tool) at baseline and at 1year

Countries

India

Contacts

Primary ContactSanjay Kr Bhadada, DM
bhadadask@rediffmail.com
Backup ContactVipin Gupta, MBBS
drvipin.gupta@yahoo.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026