At a glance
ClinicalIndex Comparison RecordN/ACompleted· 103 enrolled
Drug / intervention
OsseoSpeed™device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating OsseoSpeed™ for Postmenopausal Osteoporosis and 2 related conditions. Completed, enrolled 103 participants across 4 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Germany, Sweden
Collaborators--
Timeline
N/ACompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2008
First PostedSep 2008
Primary CompletionNov 2017
Study CompletionNov 2017
TodayJul 2026
First PostedSep 3, 2008
Enrollment StartJul 16, 2008
Primary CompletionNov 1, 2017
Study CompletionNov 15, 2017
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 17.8 years ago
Interventions
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