Phase 1
N=60
Transition From Alendronate to Romosozumab (AMG 785)
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT01588509 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine — 2.13; 2.08 percent change — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Romosozumab (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- Female
- Sponsor
- Amgen
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine |
2.13; 2.08 | 0.002 sig |
| SECONDARY Percent Change From Baseline in Bone Mineral Density (BMD) at the Femoral Neck |
2.06; 1.92 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Bone Mineral Density (BMD) at the Total Hip |
1.38; 1.40 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Serum Type-1 Aminoterminal Propeptide (P1NP) |
22.1263; 30.4935; 140.9970; 218.4994; 128.3936; 221.9954 | — |
| SECONDARY Percent Change From Baseline in Serum C-telopeptide (sCTX) |
-28.2149; -14.8099; -28.9365; -22.2800; 3.1008; -1.8188 | — |
| SECONDARY Number of Participants With Adverse Events |
14; 15; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Who Developed Anti-romosozumab Antibodies |
2; 2; 0; 0 | — |
| SECONDARY Mean Serum Concentration of Romosozumab |
15000; 23200; 10500; 18500; 3890; 8200 | — |
Summary
The purpose of this study is to estimate the percent change from baseline in lumbar spine bone mineral density (BMD) following multiple-dose administrations of romosozumab in postmenopausal women with low BMD previously treated with alendronate.
Eligibility Criteria
Inclusion Criteria
- Postmenopausal women, defined as no vaginal bleeding or spotting for ≥ 12 months
- Low bone mineral density at screening [defined by a bone mineral density (BMD) T-score ≤ -2.0 and ≥ -4.0 at the lumbar spine (L1 to L4; or BMD T-score of evaluable vertebrae), total hip, or femoral neck]
- Currently taking alendronate (70 mg weekly or equivalent) exclusively for ≥ 1 year with verbal agreement that the subject has taken ≥ 80% of their doses with good tolerance
Exclusion Criteria
- History of vertebral fracture, or fragility fracture of the wrist, humerus, hip or pelvis after age 50; or recent bone fracture within 6 months prior to screening
- History of metabolic or bone disease such as Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome
- Vitamin D deficiency (defined as 25-OH-VitD levels < 20 ng/mL)
Data sourced from ClinicalTrials.gov (NCT01588509). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.