Postmenopausal OsteoporosisNCT00745121
Study Evaluating ASTRA TECH Implant System, OsseoSpeed™ Implants in the Upper Jaw in Women With Osteoporosis
A study testing OsseoSpeed™ in people with Postmenopausal Osteoporosis and Osteopenia, run by Dentsply Sirona Implants and Consumables at 4 sites in 3 countries.
Trial summary
The overall objective of the study is to compare treatment with the ASTRA TECH Implant System, OsseoSpeed™ implant in the maxilla of postmenopausal women with and without systemic osteoporosis. The hypothesis is that there will be no difference in marginal bone level alterations between the two groups. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Postmenopausal Osteoporosis, Osteopenia, Jaw, Edentulous, Partially
- What is being tested?
- OsseoSpeed™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 16 Jul 2008to 15 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent
- Postmenopausal women aged 60 years and over
- In need of 2-8 implants in maxilla
- A history of edentulism in the area of implant treatment of at least 6 months.
- A Bone Mineral Density (BMD) value suitable either for group A or group B:
- Group A (Osteoporosis/osteopenia): BMD at least 2 standard deviations (SD) below mean peak bone density of young adults for the spine and total hip (T-score = -2 SD or less). Absolute values (g/cm2) will be used.
- Group B (Control): BMD not more than 1 standard deviation below mean peak bone density of young adults for the spine and total hip (T-score = -1 SD or more). Absolute values (g/cm2) will be used.
Who cannot join
- Unlikely to be able to comply with study procedures, as judged by the investigator.
- Untreated, uncontrolled caries and/or periodontal disease
- Known or suspected current malignancy
- History of chemotherapy within 5 years prior to surgery
- History of radiation in the head and neck region
- History of other metabolic bone diseases, e.g. Paget's disease, hyperparathyroidism, fibrous dysplasia or osteomalacia
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- A medical history that makes implant insertion unfavourable
- Need for systemic corticosteroids
- Current or previous use of intravenous bisphosphonates (esp. zoledronic acid)
- Current or previous use of oral bisphosphonates
- History of bone grafting and/or sinus lift in the planned implant area
- Current need for bone grafting and/or sinus lift in the planned implant area
- Present alcohol and/or drug abuse
- Involvement in the planning and conduct of the study (applies to both Astra Tech AB staff or staff at the study site)
- Previous enrolment in the present study.
- Participation in a clinical study during the last 6 months.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Sweden2 sites
Department of Oral and Maxillofacial Surgery, Gothenburg University
Gothenburg, SE-405 30
Käkkirurgiska kliniken, Akademiska sjukhuset
Uppsala, S-751 85
Belgium1 site
Department of Periodontology, Faculty of Medicine, Catholic University of Leuven
Leuven, B-3000
About this study
Official title: An Open, Prospective, Non-randomized, Controlled, Multicenter Study to Evaluate Clinical Outcome of the ASTRA TECH Implant System, OsseoSpeed™ Implant in Women Over 60 Years of Age With Osteoporosis/Osteopenia
The overall objective of the study is to compare treatment with the ASTRA TECH Implant System, OsseoSpeed™ implant in the maxilla of postmenopausal women with and without systemic osteoporosis. The hypothesis is that there will be no difference in marginal bone level alterations between the two groups.
- Being tested
- OsseoSpeed™
- Medical subject headings
- Osteoporosis, Postmenopausal, Bone Diseases, Metabolic, Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsseoSpeed™Device
ASTRA TECH Implant System, OsseoSpeed™ implants Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm
| Study group | Role | What they receive |
|---|---|---|
| Group-A, Osteoporosis/osteopenia | Experimental | Patients with osteoporosis/osteopenia. Receives: Device: OsseoSpeed™ |
| Group-B, Control | Experimental | Control (non-osteoporotic/-osteopenic patients). Receives: Device: OsseoSpeed™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone Level Alterations
Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 5 year follow-up visit compared to values obtained at time of loading of the permanent restoration (baseline).
Measured: Evaluated at time of loading of the permanent restoration and at the 5 years follow-up after loading.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study start16 Jul 2008
- Primary completion1 Nov 2017
- Study completion15 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Quirynen, Prof., Dr., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745121
- Sponsor's protocol ID
- YA-OSS-0007
- Status last verified
- Nov 2019
- First submitted
- 2 Sep 2008
- Last updated
- 26 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Merheb J, Temmerman A, Coucke W, Rasmusson L, Kubler A, Thor A, Quirynen M. Relation between Spongy Bone Density in the Maxilla and Skeletal Bone Density. Clin Implant Dent Relat Res. 2015 Dec;17(6):1180-7. doi: 10.1111/cid.12228. Epub 2014 Jun 6.
PubMed 24909074Merheb J, Temmerman A, Rasmusson L, Kubler A, Thor A, Quirynen M. Influence of Skeletal and Local Bone Density on Dental Implant Stability in Patients with Osteoporosis. Clin Implant Dent Relat Res. 2016 Apr;18(2):253-60. doi: 10.1111/cid.12290. Epub 2016 Feb 10.
PubMed 26864614Temmerman A, Rasmusson L, Kubler A, Thor A, Quirynen M. An open, prospective, non-randomized, controlled, multicentre study to evaluate the clinical outcome of implant treatment in women over 60 years of age with osteoporosis/osteopenia: 1-year results. Clin Oral Implants Res. 2017 Jan;28(1):95-102. doi: 10.1111/clr.12766. Epub 2016 Jan 7.
PubMed 26744141Temmerman A, Rasmusson L, Kubler A, Thor A, Merheb J, Quirynen M. A Prospective, Controlled, Multicenter Study to Evaluate the Clinical Outcome of Implant Treatment in Women with Osteoporosis/Osteopenia: 5-Year Results. J Dent Res. 2019 Jan;98(1):84-90. doi: 10.1177/0022034518798804. Epub 2018 Sep 11.
PubMed 30205020
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Prospective, Non-randomized, Controlled, Multicenter Study to Evaluate Clinical Outcome of the ASTRA TECH Implant System, OsseoSpeed™ Implant in Women Over 60 Years of Age With Osteoporosis/Osteopenia
- ClinicalTrials.gov ID
- NCT00745121
- Acronym / sponsor ID
- YA-OSS-0007
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2008
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Posted 26 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of the study is to compare treatment with the ASTRA TECH Implant System, OsseoSpeed™ implant in the maxilla of postmenopausal women with and without systemic osteoporosis. The hypothesis is that there will be no difference in marginal bone level alterations between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-A, Osteoporosis/osteopenia | Experimental | Device: OsseoSpeed™Patients with osteoporosis/osteopenia. |
| Group-B, Control | Experimental | Device: OsseoSpeed™Control (non-osteoporotic/-osteopenic patients). |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of informed consent
- Postmenopausal women aged 60 years and over
- In need of 2-8 implants in maxilla
- A history of edentulism in the area of implant treatment of at least 6 months.
- A Bone Mineral Density (BMD) value suitable either for group A or group B:
Key exclusion criteria (16 listed)
- Unlikely to be able to comply with study procedures, as judged by the investigator.
- Untreated, uncontrolled caries and/or periodontal disease
- Known or suspected current malignancy
- History of chemotherapy within 5 years prior to surgery
- History of radiation in the head and neck region
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 |
|---|---|---|
| OsseoSpeed™ASTRA TECH Implant System, OsseoSpeed™ implants Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm | Device | Group-A, Osteoporosis/osteopenia, Group-B, Control |
Primary outcome
Marginal Bone Level Alterations
Time frame: Evaluated at time of loading of the permanent restoration and at the 5 years follow-up after loading.
Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 5 year follow-up visit compared to values obtained at time of loading of the permanent restoration (baseline).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24909074Merheb J, Temmerman A, Coucke W, Rasmusson L, Kubler A, Thor A, Quirynen M. Relation between Spongy Bone Density in the Maxilla and Skeletal Bone Density. Clin Implant Dent Relat Res. 2015 Dec;17(6):1180-7. doi: 10.1111/cid.12228. Epub 2014 Jun 6.
- Results publication: PubMed 26864614Merheb J, Temmerman A, Rasmusson L, Kubler A, Thor A, Quirynen M. Influence of Skeletal and Local Bone Density on Dental Implant Stability in Patients with Osteoporosis. Clin Implant Dent Relat Res. 2016 Apr;18(2):253-60. doi: 10.1111/cid.12290. Epub 2016 Feb 10.
- Results publication: PubMed 26744141Temmerman A, Rasmusson L, Kubler A, Thor A, Quirynen M. An open, prospective, non-randomized, controlled, multicentre study to evaluate the clinical outcome of implant treatment in women over 60 years of age with osteoporosis/osteopenia: 1-year results. Clin Oral Implants Res. 2017 Jan;28(1):95-102. doi: 10.1111/clr.12766. Epub 2016 Jan 7.
- Results publication: PubMed 30205020Temmerman A, Rasmusson L, Kubler A, Thor A, Merheb J, Quirynen M. A Prospective, Controlled, Multicenter Study to Evaluate the Clinical Outcome of Implant Treatment in Women with Osteoporosis/Osteopenia: 5-Year Results. J Dent Res. 2019 Jan;98(1):84-90. doi: 10.1177/0022034518798804. Epub 2018 Sep 11.
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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.
Marc Quirynen, Prof., Dr. principal investigator
KU Leuven
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OsseoSpeed™ in people with Postmenopausal Osteoporosis and Osteopenia, run by Dentsply Sirona Implants and Consumables at 4 sites in 3 countries.
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 7 inclusion and 16 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 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden, Belgium, Germany. 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?
Yes. Results are posted in the registry (first posted 26 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Marginal Bone Level Alterations (time frame: Evaluated at time of loading of the permanent restoration and at the 5 years follow-up after loading.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00745121, which also lists 4 linked publications.
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 26 Nov 2019.