Postmenopausal Osteoporosis
Conditions
Keywords
Osteoporosis
Brief summary
The primary objective of this study is to determine the effect of treatment with AGA2118 versus placebo at Month 12 on lumbar spine bone mineral density (BMD) in postmenopausal women with low bone mass.
Detailed description
This Phase 2 dose-finding study will evaluate the safety, tolerability, and efficacy of AGA2118 at a range of dosing regimens in postmenopausal women with low BMD at the lumbar spine, total hip, or femoral neck and no prior history of fragility fractures. This study includes a 12 month blinded treatment phase where participants will be randomized 1:1:1:1:1:1:1 to receive double-blind dosing regimens of AGA2118 or placebo. At Month 12, participants who have completed the double-blind portion of the study will continue on to a 12 month open-label period where they will be re-randomized based on their prior dosing regimen to either continue their current dosing regimen, receive a new dosing regimen, or discontinue treatment and be actively surveilled throughout Months 12 to 24.
Interventions
DRUGAGA2118
Subcutaneous injection
OTHERPlacebo
Subcutaneous injection
Sponsors
Angitia Biopharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Healthy, ambulatory, postmenopausal women age ≥ 55 to ≤ 80. * BMD T-score of ≤ -2.5 to \> -3.5 at the lumbar spine, total hip, or femoral neck.
Exclusion criteria
* History of vertebral fracture, or fragility fracture of the wrist, humerus, proximal femur, or pelvis. * Vitamin D deficiency. * Known intolerance to calcium or vitamin D supplements. * Untreated hyper- or hypothyroidism. * Current hyper- or hypoparathyroidism. * Elevated transaminases. * Significantly impaired renal function. * Current hypo- or hypercalcemia. * Positive for HIV, hepatitis C virus, or hepatitis B surface antigen. * Malignancy within the last 5 years. * Diagnosis of a familial cancer syndrome or known genetic mutation that increases risk of cancer. * Myocardial infarction or stroke within the past 12 months. * Use of agents affecting bone metabolism.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change from Baseline to Month 12 in lumbar spine bone mineral density | 12 months | To determine the effect of treatment with AGA2118 versus placebo at Month 12 on the percent change from Baseline in bone mineral density at the lumbar spine in postmenopausal women with low bone mineral density |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change from Baseline to Months 3 and 6 in lumbar spine, total hip, femoral neck, and one-third distal radius bone mineral density | 3 and 6 months | To evaluate the effect of treatment with AGA2118 versus placebo at different timepoints on percent change from Baseline in bone mineral density at the lumbar spine, total hip, femoral neck, and one-third distal radius |
| Percent change from Baseline to Month 12 in total hip, femoral neck, and one-third distal radius bone mineral density | 12 months | To evaluate the effect of treatment with AGA2118 versus placebo at different timepoints on percent change from Baseline in bone mineral density at the lumbar spine, total hip, femoral neck, and one-third distal radius |
| Percent change from Baseline to Months 1, 3, 6, 9, and 12 in P1NP and CTX-1 | 1, 3, 6, 9, and 12 months | To evaluate the effect of treatment with AGA2118 versus placebo at different time points on percent change from Baseline in P1NP and CTX-1 |
| Incidence of new clinical fractures (vertebral and nonvertebral) between Baseline and Month 12 | 12 months | To evaluate the incidence of new clinical fractures (vertebral and nonvertebral) from Baseline to Month 12 |
Countries
Argentina, Poland, Ukraine, United States
Contacts
STUDY_DIRECTORRicardo Dent-Acosta, MD
Angitia Incorporated Limited
Outcome results
None listed