Weekly vs Daily Teriparatide Therapy in Severe Postmenopausal Osteoporosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PTH Comparison in Post Menopausal Women

NCT00543218

Osteoporosis, Post-Menopausal

COMPLETED PHASE3

Combined Administration of Teripapartide and Antiresorptive Agents in Postmenopausal Osteoporosis

NCT01535027

Osteoporosis

COMPLETED PHASE4

Comparison Medications in the Treatment of Postmenopausal Women With Osteoporosis

NCT00542984

Osteoporosis, Postmenopausal

COMPLETED PHASE3

Back Pain in Patients With Severe Osteoporosis

NCT00761332

Osteoporosis

COMPLETED

Effects of Teriparatide (PTH) on Bone in Men and Women With Osteoporosis

NCT01155232

Osteoporosis

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Daily Teriparatide group

This group will recieve 20µg of teriparatide by subcutaneous route daily at 8 pm for 1 year

Group Type ACTIVE_COMPARATOR

Teriparatide

Intervention Type DRUG

Weekly Teriparatide group

This group will recieve 60µg of teriparatide by subcutaneous route weekly at 8pm on Sunday for 1 year

Group Type EXPERIMENTAL

Teriparatide

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Teriparatide

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No