Mechanisms of Anabolic Osteoporosis Therapy
ConditionOsteoporosis, Postmenopausal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45+
SponsorMassachusetts General Hospital
About this trial
The aim of this study is to investigate the effect of romosozumab on bone cells during early and late phases of treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female aged > 45 years
> 36 since last spontaneous menses
> 36 months since hysterectomy, plus serum FSH > 40 units / liter if < 60 years
Disqualifiers
renal disease (stage 4 CKD)
elevated blood PTH (intact PTH > 77 pg/ml).
serum 25-OH vitamin D < 20 ng/ml
major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
Trial design
Design model
Parallel
Treatments tested in this trial
early versus late biopsy
Other interventionearly (3-6 weeks) versus late (6-8 months) biopsy
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: Early BiopsyActive comparator 1 intervention
Group B: Late BiopsyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Osteoblast progenitor cell numbers
The investigators are testing the mechanistic hypothesis that romosozumab treatment increases osteoblast progenitor cell numbers at early, but not late, treatment time points.
Time frame
3-6 weeks (early) versus 6-8 months (late)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov