OsteoporosisNCT01760798
Weekly vs Daily Teriparatide Therapy in Severe Postmenopausal Osteoporosis
A study testing Teriparatide in people with Osteoporosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Teriparatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women of age group 50-70 having T score less than -2.5 SD or lower at lumbar spine or proximal femur.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sanjay Kr Bhadada, DM contact
Vipin Gupta, MBBS contact
India1 site, 1 recruiting
- Recruiting
PGIMER
Chandigarh, Uttarakhand, 1600012
Sanjay Kr Bhadada, DM, bhadadask@rediffmail.com
Sanjay Kr Bhadada, DM
About this study
Official title: 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.
- Conditions
- Osteoporosis
- Being tested
- Teriparatide
- Keywords
- osteoporosis, Teriparatide
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
| Study group | Role | What they receive |
|---|---|---|
| Daily Teriparatide group | Active comparator | This group will recieve 20µg of teriparatide by subcutaneous route daily at 8 pm for 1 year Receives: Drug: Teriparatide |
| Weekly Teriparatide group | Experimental | This group will recieve 60µg of teriparatide by subcutaneous route weekly at 8pm on Sunday for 1 year Receives: Drug: Teriparatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMD at Hip and lumber spine
DEXA scan(BMD at hip and lumbar spine) at baseline and at the end of 1 year
Measured: 1 year
Reduction in fracture risk
Reduction in fracture risk using online FRAX tool( WHO fracture risk assessment tool) at baseline and at 1year
Measured: 6 week, 6 month and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startJan 2012
- Primary completionJun 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjay K. Bhadada, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Sanjay Kr Bhadada, DM, Principal investigator, Associate Professor, Department of Endocrinology, PGIMER Chandigarh India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760798
- Sponsor's protocol ID
- teriparatide
- Status last verified
- Apr 2014
- First submitted
- 2 Jan 2013
- Last updated
- 16 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare Efficacy of Weekly Versus Daily Teriparatide in the Management of Postmenopausal Osteoporosis
- ClinicalTrials.gov ID
- NCT01760798
- Acronym / sponsor ID
- teriparatide
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, Teriparatide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 4 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily Teriparatide group | Active comparator | Drug: TeriparatideThis group will recieve 20µg of teriparatide by subcutaneous route daily at 8 pm for 1 year |
| Weekly Teriparatide group | Experimental | Drug: TeriparatideThis group will recieve 60µg of teriparatide by subcutaneous route weekly at 8pm on Sunday for 1 year |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal women of age group 50-70 having T score less than -2.5 SD or lower at lumbar spine or proximal femur.
Key exclusion criteria (7 listed)
- Patients with renal dysfunction (serum creatinine >1.5)
- Primary and secondary hyperparathyroidism
- Secondary osteoporosis
- Unexplained elevated ALP (alkaline phosphatase)
- History of therapeutic radiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teriparatide | Drug | Daily Teriparatide group, Weekly Teriparatide group |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay Kr Bhadada, DM contact
Vipin Gupta, MBBS contact
Sanjay Kr Bhadada, DM principal investigator
Associate Professor, Department of Endocrinology, PGIMER Chandigarh India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teriparatide in people with Osteoporosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanjay Kr Bhadada, DM (bhadadask@rediffmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMD at Hip and lumber spine (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2014.