OsteoporosisNCT00347737
The Effects of Therapy With Teriparatide on Vascular Compliance and Osteoprotegerin/RANKL
A study testing teriparatide in people with Osteoporosis, run by Leland Graves III, MD at 1 site in United States.
Trial summary
The purpose of this study is to determine what effect teriparatide will have on vascular (blood vessel) compliance and osteoprotegerin (bone fluid)and RANKL levels (bone cells). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- teriparatide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to May 2008
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women and men over the age of 40 who are starting therapy with teriparatide
Who cannot join
- Patients with diabetes mellitus
- current smokers
- patients with a history of organ transplantation
- Patients currently of previously on glucocorticoid therapy within the past year
- Patients with serum creatinine above 1.5 mg/dl, patients with uncontrolled hypertension (BP 140/90 or greater)
- Patients ineligible for teriparatide therapy: History of metabolic bone disease other than osteoporosis
Show all 10Show fewer
- History of radiation therapy
- Patients pregnant or nursing
- History of bone metastasis or skeletal malignancies
- History of hypercalcemia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: The Effects of Therapy With Teriparatide (Recombinant Parathyroid Hormone (1-34) on Vascular Compliance and Osteoprotegerin/RANKL
The purpose of this study is to determine what effect teriparatide will have on vascular (blood vessel) compliance and osteoprotegerin (bone fluid)and RANKL levels (bone cells).
Read the detailed description
Research subjects participation is about 6 months. Subjects will give themselves daily injections of teriparatide after instruction on technique.
- Conditions
- Osteoporosis
- Being tested
- 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
Also called Forteo
Teriparatide
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Teriparatide Receives: Drug: teriparatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The study measures changes in vascular compliance with teriparatide 1 hour, 3 months, and 6 months after initiating teriparatide. Osteoprotegerin and RANKL levels
Measured: baseline, 3, and 6 months
Secondary outcomes (1)
CRP levels
Measured: Baseline and at 6 months of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionMay 2008
- Study completionMay 2008
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leland Graves III, MD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas
- Responsible party
- Sponsor-investigator, Leland Graves III, MD, University of Kansas Medical Center
- Investigators
- Leland Graves, III, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347737
- Sponsor's protocol ID
- 10386
- Status last verified
- Jan 2013
- First submitted
- 30 Jun 2006
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Therapy With Teriparatide (Recombinant Parathyroid Hormone (1-34) on Vascular Compliance and Osteoprotegerin/RANKL
- ClinicalTrials.gov ID
- NCT00347737
- Acronym / sponsor ID
- 10386
- Conditions
- Osteoporosis
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Leland Graves III, MDUniversity, hospital or other
- Collaborators
- University of Kansas
- Study start
- Jun 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 4 Jul 2006 (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.
The purpose of this study is to determine what effect teriparatide will have on vascular (blood vessel) compliance and osteoprotegerin (bone fluid)and RANKL levels (bone cells).
Detailed description
Research subjects participation is about 6 months. Subjects will give themselves daily injections of teriparatide after instruction on technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: teriparatideTeriparatide |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal women and men over the age of 40 who are starting therapy with teriparatide
Key exclusion criteria (10 listed)
- Patients with diabetes mellitus
- current smokers
- patients with a history of organ transplantation
- Patients currently of previously on glucocorticoid therapy within the past year
- Patients with serum creatinine above 1.5 mg/dl, patients with uncontrolled hypertension (BP 140/90 or greater)
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 |
|---|---|---|
| teriparatideAlso: ForteoTeriparatide | Drug | 1 |
Primary outcome
The study measures changes in vascular compliance with teriparatide 1 hour, 3 months, and 6 months after initiating teriparatide. Osteoprotegerin and RANKL levels
Time frame: baseline, 3, and 6 months
1 secondary outcome
CRP levels
Time frame: Baseline and at 6 months of therapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
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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.
Leland Graves, III, MD principal investigator
University of Kansas Medical Center
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 Leland Graves III, MD at 1 site in United States.
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 10 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: withdrawn, as of the sponsor's last update on 16 Jan 2013. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The study measures changes in vascular compliance with teriparatide 1 hour, 3 months, and 6 months after initiating teriparatide. Osteoprotegerin and RANKL levels (time frame: baseline, 3, and 6 months). 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 Jan 2013.