Romosozumab in Women With Chronic SCI

Korábbi kezelés

• History of alcoholism or drug abuse within the 2 years prior to study screening, which in the opinion of the investigator may affect subject's health and/or study commitment
• Current or use during past 5 years of any bone-active agents, including any FDA approved treatment (e.g., teriparatide, abaloparatide, denosumab, any bisphosphonate (oral or IV), raloxifene, bazedoxifene, hormone therapy (estrogen and estrogen/progestin) and calcitonin) as well as any strontium-containing compounds.

Más betegség

• Have Paget's disease of the bone
• Any active gastrointestinal condition that results in malabsorption
• Known hypersensitivity to romosozumab or alendronate
• Osteonecrosis of the jaw (ONJ) or risk factor for ONJ, such as invasive dental procedures (e.g., tooth extraction, dental implants, oral surgery in the past 6 months), poor oral hygiene, periodontal and/or pre-existing dental disease, or planned invasive dental procedure over the next two years
• History of bone metastasis and skeletal malignancies
• Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study
• Any history of stroke or cardiovascular disease other than controlled hypertension
• Any other neurological impairment that may impair ambulation or muscle function

Laborértékek

• Have abnormal laboratory values that in the judgement of the investigator would put the participant at increased risk of treatment
• Renal insufficiency (calculated creatinine clearance less than 35 ml/min)

Egyéb

• Abnormalities of the esophagus which delay emptying such as stricture or achalasia
• Increased risk of aspiration
• Heterotopic ossification of the knee region that interferes with CT analysis
• Currently being prescribed anticonvulsants at a dose or frequency that is determined to interfere with bone metabolism as determined by the investigator
• Currently being prescribed glucocorticoids, other than inhaled glucocorticoids
• Pregnant, planning to become pregnant, or lactating

• Age ≥18 years
• Female sex
• SCI 6 or more months prior to enrollment
• Non-ambulatory status (Walking Index for Spinal Cord Injury II score of 3 or less)
• Osteoporosis by DXA defined as a t-score of -2.5 at any skeletal site (lumbar spine, total hip, or femoral neck) or a t-score of -2.0 plus a history of a fragility fracture
• Good general health, as determined by the study investigator
• Able to understand and agree to informed consent in English
• Able and willing to complete all the study visits
• Females of childbearing potential must be willing and able to use an effective method of contraception or practice abstinence throughout the course of the study and up to 90 days after the last use of study drug.
• Vitamin D 25-hydroxy levels ≥ 20 ng/ml (subjects may be repleted and retested prior to baseline)
• Normal serum calcium levels (based on current local laboratory normal range)
• No known endocrinopathies (diabetes type 1 or 2, treated thyroid conditions can be included)
• Normal serum thyroid stimulating hormone and/or T4 levels (based on current local laboratory normal ranges)
• Able to take oral medication sitting upright for at least 30 minutes