A daily injection that builds new bone rather than slowing its loss. Spine fractures fall sharply, fractures elsewhere fall substantially, and bone density rises at every site measured — in men, in women, and in the very old. Gains hold only when a bone-preserving drug follows the course. Almost every trial was designed and funded by the maker. (Full Review)
| Marker | Target | Why |
|---|---|---|
| Serum calcium (albumin-corrected) | 8.8–10.0 mg/dL | Detects the drug's principal biochemical toxicity |
| 25-hydroxyvitamin D | 40–60 ng/mL | Determines whether new bone can mineralise |
| Parathyroid hormone (PTH) | 15–35 pg/mL | Excludes hyperparathyroidism, which contraindicates treatment |
| Alkaline phosphatase | 50–90 U/L | Unexplained elevation flags Paget's disease or skeletal malignancy |
| P1NP (procollagen type I N-terminal propeptide) | Rise of ≥40% from the individual's own baseline by 3 months | Confirms the bone-building signal has engaged |
| CTX | Below the pretreatment baseline or modestly above | Shows whether resorption is tracking formation |
| 24-hour urine calcium | 100–250 mg/24 h | Detects hypercalciuria before stones form |
| Estimated glomerular filtration rate (eGFR) | ≥60 mL/min/1.73 m² | Governs calcium and peptide clearance |
| Serum uric acid | 3.5–6.0 mg/dL | Rises predictably on treatment; matters in gout |
| Lumbar spine and total hip DXA T-score | Improvement toward better than −2.5 | The endpoint the whole course is aimed at |
| Trabecular bone score (TBS) | Above 1.31, or rising from own baseline | Captures bone structure that density alone misses |
Cadence: Serum calcium at 4 weeks and after any dose or co-medication change; bone turnover markers at 3 months; calcium and kidney function every 6 months thereafter; repeat DXA at 12 and 24 months