CoxarthrosisNCT00317863
Zink and Bone Strength
An observational study of Coxarthrosis and Fracture of Femoral Neck, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
Zink and bone strength Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Coxarthrosis, Fracture of Femoral Neck
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2004to 1 Jan 2008
- Phase
- Observational
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: blood- and urine samples collected from 20 OA patients and 20 osteoporosis patients who all had a hip-replacement. All patients were evaluated by DEXA-scanning.
Who may be able to join
- Postmenopausal women with osteoarthrosis or femoral neck-fracture i one hip
Who cannot join
- pathology or prosthesis in contralateral hip
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Northern Orthopaedic Division, Klinik Farsoe
Farsø, Northern Jutland
About this study
Zink and bone strength
Read the detailed description
blood- and urine samples collected from 20 OA patients and 20 osteoporosis patients who all had a hip-replacement. All patients were evaluated by DEXA-scanning.
- Conditions
- Coxarthrosis, Fracture of Femoral Neck
- Medical subject headings
- Osteoarthritis, Hip
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2006 (estimated)
- Study startJan 2004
- Primary completion1 Jan 2008
- Study completion1 Jan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoxarthrosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janne Ovesen, MD, Principal investigator, Northern Orthopaedic Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317863
- Sponsor's protocol ID
- ON-04-003-JO
- Status last verified
- Sep 2017
- First submitted
- 23 Apr 2006
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zink and Bone Strength
- ClinicalTrials.gov ID
- NCT00317863
- Acronym / sponsor ID
- ON-04-003-JO
- Conditions
- Coxarthrosis, Fracture of Femoral Neck
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- Jan 2004 (actual)
- Primary completion
- 1 Jan 2008 (actual)
- Study completion
- 1 Jan 2008 (actual)
- First posted
- 25 Apr 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.
Zink and bone strength
Detailed description
blood- and urine samples collected from 20 OA patients and 20 osteoporosis patients who all had a hip-replacement. All patients were evaluated by DEXA-scanning.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- blood- and urine samples collected from 20 OA patients and 20 osteoporosis patients who all had a hip-replacement. All patients were evaluated by DEXA-scanning.
Key inclusion criteria (1 listed)
- Postmenopausal women with osteoarthrosis or femoral neck-fracture i one hip
Key exclusion criteria (1 listed)
- pathology or prosthesis in contralateral hip
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Final publicationLink provided by the sponsor.
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Z1 Hip System: Post-Market Clinical Follow Up Study
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DEXA Bone Density Analysis of the CoreHip® Prosthesis System
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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.
Janne Ovesen, MD principal investigator
Northern Orthopaedic Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coxarthrosis and Fracture of Femoral Neck, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
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 1 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: finished, as of the sponsor's last update on 15 Sep 2017. 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 Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 15 Sep 2017.