Postmenopausal osteoporosis MedDRA version: 19.1 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: romosozumab
Product Code: AMG785
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: romosozumab
Current Sponsor code: AMG785
Other descriptive name: R
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures. OR • Subject’s legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent. • Females who were initially randomized to the romosozumab to ALN sequential treatment arm of the ARCH study and - who have completed the Month 36 visit of the ARCH study - who did not discontinue investigational product during the ARCH study and therein received at least 75% of planned romosozumab and ALN dosing • Subject meets the following BMD criteria - Subject has a DXA BMD T-score = -2.0 at the total hip or femoral neck (at or within 4 weeks of the start of screening), as assessed by imaging vendor. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: Disease Related • Subjects with a positively adjudicated osteonecrosis of the jaw (ONJ) or atypical femoral fracture (AFF) event in the ARCH study or any history of ONJ or AFF events. • Vitamin D insufficiency (defined as 25 (OH) vitamin D levels 10. • Current, uncontrolled hyperparathyroidism or history of hypoparathyroidism, per subject report or chart review. Uncontrolled hyperparathyroidism is defined as: PTH outside the normal range in subjects with concurrent hypercalcemia; or PTH values > 20% above the upper limit of normal (ULN) in normocalcemic subjects. • Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range, as assessed by the central laboratory. Albumin-adjusted serum calcium levels may be retested once in case of an elevated albumin-adjusted serum calcium level within 1.1 x the ULN as assessed by the central laboratory. • History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as sclerosteosis, Paget’s disease. Other Medical Conditions • Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years from the start of this study. • Possible diagnosis of multiple myeloma or related lymphoproliferative disorder, as assessed by serum protein electrophoresis performed by the local laboratory (electrophoresis results within 6 months of signing consent will be acceptable). • Positive for Hepatitis B. • Positive for Hepatitis C, Chronic Hepatitis C, and negative viral load while receiving treatment for Hepatitis C. • Positive results for Human Immunodeficiency Virus (HIV) or known to be HIV-positive Prior/Concomitant Therapy • Subjects who have stopped taking ALN for > 3 months since ending the ARCH study and prior to enrollment in this study. • Use of strontium ranelate, or fluoride (for osteoporosis): more than 1 month of cumulative use within 5 years prior to randomization for, during, or after completion of the ARCH study. • Use of Intravenous (IV) bisphosphonates. - Zoledronic acid: o any dose received within 3 years prior to randomization for, during, or after completion of the ARCH study o more than 1 dose received within 5 years prior to randomization for, during, or after completion of the ARCH study - IV ibandronate or IV pamidronate: o any dose received within 12 months prior to randomization for, during, or after completion of the ARCH study o more than 3 years of cumulative use, unless last dose received = 5 years prior to randomization for the ARCH study o Use of oral bisphosphonates: - any dose received within 3 months prior to randomization for, during, or after completion of the ARCH study - more than 1 month of cumulative use between 3 and 12 months prior to randomization for, during, or after completion of the ARCH study - more than 3 years of cumulative use, unless last dose received = 5 years prior to randomization for the ARCH study • Use of denosumab or any cathepsin K inhibitor, such as odanacatib (MK-0822): any dose received within 18 mont
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To describe the effect of 12 months of treatment with romosozumab versus alendronate (ALN) on the percent change in dual-energy X-ray absorptiometry (DXA) bone mineral density (BMD) at the lumbar spine in postmenopausal women with osteoporosis previously treated with romosozumab followed by ALN sequential therapy.;Secondary Objective: • To describe the effect of 12 months of treatment with romosozumab versus ALN in postmenopausal women with osteoporosis previously treated with romosozumab followed by ALN sequential therapy on the following: o percent change in DXA BMD at the total hip and femoral neck o percent change in bone turnover markers (BTMs) • To describe the effect of 12 months of treatment with romosozumab followed by 12 months of ALN versus 24 months of ALN in postmenopausal women with osteoporosis previously treated with romosozumab followed by ALN sequential therapy on the following: o percent change in DXA BMD at the lumbar spine, total hip, and femoral neck ;Primary end point(s): • Percent change from baseline to Month 12 in DXA BMD at the lumbar spine ;Timepoint(s) of evaluation of this end point: Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percent change from baseline to Month 6 and Month 24 in BMD at the lumbar spine • Percent change from baseline to Months 6, 12, and 24 in BMD at the total hip and femoral neck • Percent change from baseline to Months 1, 3, 6, and 12 in Procollagen Type 1 N-telopeptide (P1NP) and Type I collagen C-telopeptide (CTX);Timepoint(s) of evaluation of this end point: Months 1, 3, 6, 12, and 24 | — |
Countries
Czech Republic, Hong Kong, Mexico, Russian Federation, South Africa
Contacts
Public ContactIHQ-Medical Info - Clinical Trials
Amgen (Europe) GmbH
Outcome results
None listed