Combined Anabolic Therapy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age45+
SponsorMassachusetts General Hospital
About this trial
In this research study the study investigators want to learn more about the effect of two different FDA-approved medication regimens in the treatment of postmenopausal osteoporosis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
women aged 45+
postmenopausal
osteoporotic with high risk of fracture
Disqualifiers
no significant previous use of bone health modifying treatments
known congenital or acquired bone disease other than osteoporosis
significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease
abnormal calcium or parathyroid hormone level
Trial design
Design model
Parallel
Treatments tested in this trial
Romosozumab
Drugromosozumab 210 milligrams monthly
Teriparatide
Drugteriparatide 20 micrograms daily
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: RomosozumabActive comparator 1 intervention
Group B: Romosozumab and TeriparatideActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Lumbar spine areal bone mineral density
Change in lumbar spine bone density between month 0 and month 12
Time frame
Month 0 to 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov