NCT01760798

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 2, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 16, 2014

Status Verified

April 1, 2014

Enrollment Period

2.4 years

First QC Date

January 2, 2013

Last Update Submit

April 15, 2014

Conditions

Osteoporosis

Keywords

osteoporosisTeriparatide

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Daily Teriparatide group

ACTIVE COMPARATOR

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

Drug: Teriparatide

Weekly Teriparatide group

EXPERIMENTAL

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

Drug: Teriparatide

Interventions

TeriparatideDRUG
Daily Teriparatide groupWeekly Teriparatide group

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women of age group 50-70 having T score less than -2.5 SD or lower at lumbar spine or proximal femur.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIMER

Chandigarh, Uttarakhand, 1600012, India

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Sanjay Kr Bhadada, DM

    Associate Professor, Department of Endocrinology, PGIMER Chandigarh India

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjay Kr Bhadada, DM

CONTACT

bhadadask@rediffmail.com

Vipin Gupta, MBBS

CONTACT

drvipin.gupta@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Dept of Endocrinology

Study Record Dates

First Submitted

January 2, 2013

First Posted

January 4, 2013

Study Start

January 1, 2012

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

April 16, 2014

Record last verified: 2014-04

Locations

IN(1)