Quanduzhong Capsules for Primary Osteoporosis

Prior treatment

• Use of any of the following medications affecting bone metabolism:
• Oral bisphosphonates meeting any of the following conditions: prior cumulative use of ≥3 years; any use within 6 months before enrollment; or cumulative use exceeding 1 month within 12 months before enrollment.
• History of denosumab use within 18 months before enrollment.
• History of teriparatide or other parathyroid hormone (PTH) analog use within 12 months before enrollment.
• Oral or transdermal use of estrogen, progestin, selective estrogen receptor modulators (raloxifene), or calcitonin with cumulative use exceeding 1 month within 6 months before enrollment.
• Androgen deprivation therapy or hormonal ablation therapy with cumulative treatment exceeding 1 month within 6 months before enrollment.
• History of tibolone or cinacalcet use within 3 months before enrollment.
• History of systemic glucocorticoid use at ≥5 mg prednisone equivalent per day for more than 10 consecutive days within 3 months before enrollment.

Other illness

• History of hip fracture.
• Presence of metabolic diseases or bone diseases that significantly affect bone metabolism (other than osteoporosis), such as Paget's disease of bone, osteomalacia, rheumatoid arthritis, gout, multiple myeloma, osteogenesis imperfecta, ankylosing spondylitis, Cushing's disease, and malabsorption syndrome.
• History of organ transplantation or bone marrow transplantation.
• History of osteonecrosis of the jaw.
• Active malignancy within the past 2 years (except skin cancer).
• History of taking Quan Duzhong Capsules within the past 6 months.
• Severe psychiatric or cognitive disorders that prevent cooperation with the investigators.

Lab values

• Known hypersensitivity to calcium and vitamin D preparations or the investigational traditional Chinese medicine preparation(s).
• Severe vitamin D deficiency (serum 25-hydroxyvitamin D \< 25 nmol/L \[10 ng/mL\]).
• Hepatic impairment (ALT or AST outside the normal range).
• eGFR \< 35 mL/min.

Other

• Intravenous bisphosphonates within 5 years before enrollment.
• Hypercalcemia or hypocalcemia.
• Uncontrolled hypothyroidism or hyperthyroidism (TSH outside the normal range).
• Uncontrolled hypoparathyroidism or hyperparathyroidism (PTH outside the normal range).

• Postmenopausal women aged 45-80 years (inclusive) or men aged 50-80 years (inclusive).
• T-score ≤ -2.50 and ≥ -3 at the axial skeleton (lumbar spine L1-L4, femoral neck, or total hip).
• Participants voluntarily participate in this study and provide written informed consent.