Study to Assess the Efficacy and Safety of Romosozumab Treatment Compared to Alendronate in Postmenopausal Women with Osteoporosis

Phase 1

• Conditions: Postmenopausal osteoporosis; MedDRA version: 19.0Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2011-003142-41-BE
• Lead Sponsor: Amgen, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-25
• Last Update Posted: 12 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 4000

Inclusion Criteria

4.1.1 Ambulatory postmenopausal women, age = 55 to = 90 years at
randomization. Postmenopausal status is defined as no vaginal bleeding
or spotting for 12 consecutive months prior to screening.
4.1.2 Subject meets at least one of the following BMD and fracture
criteria
BMD T-score = -2.50 at the total hip or femoral neck AND EITHER at
least one moderate (SQ2) or severe (SQ3) vertebral
fracture OR at least 2 mild (SQ1) vertebral fractures
or
BMD T-score = -2.00 at the total hip or femoral neck AND EITHER at
least 2 moderate (SQ2) or severe (SQ3) vertebral fractures OR a fracture
of the proximal femur that occurred within 3 to 24 months prior to
randomization
BMD T-scores at the time of screening will be assessed by the central
imaging vendor based on DXA scans and using data for Caucasian
women from the National Health and Nutritional Examination Survey
(NHANES) 1998.
Vertebral fractures at the time of screening will be assessed by the
central imaging vendor based on lateral spine x-rays.
History of proximal femur fracture will be assessed by the principal investigator based on discharge summary, radiology report, or
comparable documentation of type and date of fracture.
4.1.3 At least one hip is evaluable by DXA, as assessed by the principal
investigator
4.1.4 Subject has provided informed consent
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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3850

Exclusion Criteria

Strontium ranelate,or fluoride (for osteoporosis): more than 1 month of
cumulative use within 5 yrs prior to randomization
-(IV) bisphosphonates
-Zoledronic acid:
-any dose received within 3 yrs prior to randomization
-more than 1 dose received within 5 yrs prior to randomization
-IV ibandronate or IV pamidronate:
-any dose received within 12 mths prior to randomization
-more than 3 yrs of cumulative use, unless last dose received = 5
yrs prior to randomization
Oral bisphosphonates:
•More than 3 yrs of cumulative use, unless last dose received = 5
yrs prior to randomization
•Any dose received within 3 mths prior to randomization
•More than 1 mth of cumulative use between 3 and 12 mths prior
to randomization
Denosumab or any cathepsin K inhibitor,such as odanacatib:any dose
received within 18 mths prior to randomization
Teriparatide or any PTH analogs:
•any dose received within 3 mths prior to randomization
•more than 1 mth of cumulative use between 3 and 12 mths
prior to randomization
Systemic oral or transdermal estrogen or SERMs:more than 1 mth of
cumulative use within 6 mths prior to randomization
Hormonal ablation therapy: more than 1 month of cumulative use within
6 months prior to randomization
Tibolone, cinacalcet or calcitonin:any dose received within 3 months
prior to randomization
Systemic glucocorticosteroids: = 5 mg prednisone equivalent per day for more than 14 days within 3 months prior to randomization
History of metabolic or bone disease (except osteoporosis) that may
interfere with the interpretation of the results, such as sclerosteosis,
Paget's disease, osteomalacia, osteogenesis imperfecta, osteopetrosis,
ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and
malabsorption syndrome
History of solid organ or bone marrow transplants
-25(OH) Vitamin D levels < 20 ng/mL as assessed by the
central laboratory.
Current hyper/hypocalcemia, defined as albumin-adjusted serum
calcium outside the normal range, as assessed by the central laboratory.
Serum calcium levels may be retested once in case of an elevated serum calcium level within 1.1x the upper limit of normal as assessed by the central laboratory.
Current, uncontrolled hyper- or hypothyroidism, per subject report or chart review. Uncontrolled hypothyroidism is defined as
TSH and T4 outside the normal range. Uncontrolled hypothyroidism is defined as TSH >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 hypercalcaemia; or PTH values >20% above the ULN in normocalcemic subjects
Possible diagnosis of multiple myeloma or related lymphoproliferative
disorder, as assessed by serum protein electrophoresis performed by the local laboratory
Exclusion criteria related to contraindications or possible signs of intolerance to ALN; contraindications and potential signs of intolerance
for ALN therapy include:
•Hypocalcemia
•Abnormalities of the esophagus, which delay esophageal emptying
such as stricture or achalasia
•Inability to stand or sit upright for at least 30 minutes
•Hypersensitivity to ALN or other constituents of ALN tablets
•Pregnancy and lactation
•Other contraindications to ALN based on the country-specific product
insert applicable to the specific study center
•Significantly impaired renal function.
General
•Subject is currently en

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified