Baseline clinical and laboratory patient characteristics along with markers of bone turnover
| Parameters . | DNM group (n = 32) . | Placebo group (n = 31) . | P . |
|---|---|---|---|
| Age, y | 52.5 (34-70) | 56.0 (36-78) | .254 |
| Sex, male/female, n | 14/18 | 16/15 | .532 |
| Hypogonadic/nonhypogonadic patients, n | 7/25 | 7/24 | .946 |
| Years from first osteoporosis diagnosis | 1.0 (0-25.8) | 0.5 (0-19.7) | .908 |
| Hb, g/dL | 8.7 (6.2-12.6) | 8.9 (7.1-11.9) | .460 |
| White blood cells, ×109/L | 9.16 (2.66-16.98) | 7.46 (3.7-31.48) | .080 |
| Platelets, ×109/L | 415 (106-860) | 276 (63-837) | .116 |
| Calcium, mg/dL | 9.4 (8.6-10.2) | 9.3 (8.7-9.9) | .295 |
| Serum creatinine, mg/dL | 0.62 (0.5-2.3) | 0.66 (0.5-1.5) | .741 |
| AST, U/L | 23.5 (8-65) | 27 (13-65) | .221 |
| ALT, U/L | 20.5 (10-65) | 20 (8-67) | .783 |
| ALP, IU/L | 85 (46-171) | 65 (39-129) | .013 |
| Total bilirubin, mg/dL | 2.01 (0.40-8.11) | 2.11 (0.52-7.24) | .394 |
| CPK, IU/L | 22 (18-56) | 32 (24-53) | .107 |
| LDH, U/L | 236 (100-439) | 267 (117-715) | .229 |
| Ferritin, ng/mL | 471.1 (62.7-2759) | 763.0 (92.3-2406) | .431 |
| Bone mineral density, g/cm2 | |||
| L1-L4 | 0.76 (0.60-0.97) | 0.77 (0.52-0.99) | .540 |
| Femoral neck | 0.60 (0.50-0.86) | 0.66 (0.48-0.85) | .352 |
| Wrist bone | 0.52 (0.20-0.64) | 0.56 (0.35-0.81) | .285 |
| Bone mineral density, T score | |||
| L1-L4 | −2.8 (−4.0 to −0.9) | −2.5 (−4 to −0.9) | .587 |
| Femoral neck | −2.25 (−3.20 to −0.50) | −1.85 (−3.30 to −0.40) | .245 |
| Wrist bone | −3.7 (−11.7 to −1.1) | −3.3 (−8.7 to −0.1) | .367 |
| Bone mineral density, Z score | |||
| L1-L4 | −1.9 (−3.6 to 0.9) | −1.9 (-4.5 to −0.3) | .855 |
| Femoral neck | −1.1 (−2.5 to 0.1) | −0.9 (−2.4 to 0.2) | .212 |
| Wrist bone | −3.10 (−11.1 to 0.70) | −2.60 (−8.30 to 1.30) | .193 |
| Markers of bone resorption | |||
| CTX, ng/mL | 0.12 (0.04-0.50) | 0.14 (0.01-0.34) | .905 |
| TRACP-5b, U/L | 0.20 (0.07-6.47) | 0.16 (0.04-0.44) | .026 |
| Markers of bone formation | |||
| bALP, U/L | 11.23 (4.73-55.52) | 11.38 (4.72-34.4) | .657 |
| OC, ng/mL | 4.49 (0.95-33.65) | 3.36 (0.57-19.6) | .263 |
| Markers of osteoclast activation | |||
| sRANKL, pmol/L | 0.28 (0.07-0.82) | 0.22 (0.05-0.82) | .916 |
| OPG, pmol/L | 3.9 (1.6-18.8) | 3.97 (0.08-11.12) | .866 |
| sRANKL/OPG | 0.06 (0.02-0.37) | 0.06 (0.01-1.27) | .983 |
| Markers of osteoblast inhibition | |||
| Sclerostin, pmol/L | 24.6 (5.2-67.4) | 22.9 (3.6-53.8) | .805 |
| DKK-1, pmol/L | 6.2 (1.5-21.1) | 5.01 (0.11-16.66) | .877 |
| Parameters . | DNM group (n = 32) . | Placebo group (n = 31) . | P . |
|---|---|---|---|
| Age, y | 52.5 (34-70) | 56.0 (36-78) | .254 |
| Sex, male/female, n | 14/18 | 16/15 | .532 |
| Hypogonadic/nonhypogonadic patients, n | 7/25 | 7/24 | .946 |
| Years from first osteoporosis diagnosis | 1.0 (0-25.8) | 0.5 (0-19.7) | .908 |
| Hb, g/dL | 8.7 (6.2-12.6) | 8.9 (7.1-11.9) | .460 |
| White blood cells, ×109/L | 9.16 (2.66-16.98) | 7.46 (3.7-31.48) | .080 |
| Platelets, ×109/L | 415 (106-860) | 276 (63-837) | .116 |
| Calcium, mg/dL | 9.4 (8.6-10.2) | 9.3 (8.7-9.9) | .295 |
| Serum creatinine, mg/dL | 0.62 (0.5-2.3) | 0.66 (0.5-1.5) | .741 |
| AST, U/L | 23.5 (8-65) | 27 (13-65) | .221 |
| ALT, U/L | 20.5 (10-65) | 20 (8-67) | .783 |
| ALP, IU/L | 85 (46-171) | 65 (39-129) | .013 |
| Total bilirubin, mg/dL | 2.01 (0.40-8.11) | 2.11 (0.52-7.24) | .394 |
| CPK, IU/L | 22 (18-56) | 32 (24-53) | .107 |
| LDH, U/L | 236 (100-439) | 267 (117-715) | .229 |
| Ferritin, ng/mL | 471.1 (62.7-2759) | 763.0 (92.3-2406) | .431 |
| Bone mineral density, g/cm2 | |||
| L1-L4 | 0.76 (0.60-0.97) | 0.77 (0.52-0.99) | .540 |
| Femoral neck | 0.60 (0.50-0.86) | 0.66 (0.48-0.85) | .352 |
| Wrist bone | 0.52 (0.20-0.64) | 0.56 (0.35-0.81) | .285 |
| Bone mineral density, T score | |||
| L1-L4 | −2.8 (−4.0 to −0.9) | −2.5 (−4 to −0.9) | .587 |
| Femoral neck | −2.25 (−3.20 to −0.50) | −1.85 (−3.30 to −0.40) | .245 |
| Wrist bone | −3.7 (−11.7 to −1.1) | −3.3 (−8.7 to −0.1) | .367 |
| Bone mineral density, Z score | |||
| L1-L4 | −1.9 (−3.6 to 0.9) | −1.9 (-4.5 to −0.3) | .855 |
| Femoral neck | −1.1 (−2.5 to 0.1) | −0.9 (−2.4 to 0.2) | .212 |
| Wrist bone | −3.10 (−11.1 to 0.70) | −2.60 (−8.30 to 1.30) | .193 |
| Markers of bone resorption | |||
| CTX, ng/mL | 0.12 (0.04-0.50) | 0.14 (0.01-0.34) | .905 |
| TRACP-5b, U/L | 0.20 (0.07-6.47) | 0.16 (0.04-0.44) | .026 |
| Markers of bone formation | |||
| bALP, U/L | 11.23 (4.73-55.52) | 11.38 (4.72-34.4) | .657 |
| OC, ng/mL | 4.49 (0.95-33.65) | 3.36 (0.57-19.6) | .263 |
| Markers of osteoclast activation | |||
| sRANKL, pmol/L | 0.28 (0.07-0.82) | 0.22 (0.05-0.82) | .916 |
| OPG, pmol/L | 3.9 (1.6-18.8) | 3.97 (0.08-11.12) | .866 |
| sRANKL/OPG | 0.06 (0.02-0.37) | 0.06 (0.01-1.27) | .983 |
| Markers of osteoblast inhibition | |||
| Sclerostin, pmol/L | 24.6 (5.2-67.4) | 22.9 (3.6-53.8) | .805 |
| DKK-1, pmol/L | 6.2 (1.5-21.1) | 5.01 (0.11-16.66) | .877 |
Bold values denote statistical significance. Values are expressed as median (range), unless otherwise specified.
bALP, bone-specific alkaline phosphatase; CTX, C-terminal crosslinking telopeptide of type I collagen; Dkk-1, dickkopf-1; LDH, lactate dehydrogenase; OC, osteocalcin; TRACP-5b, tartrate-resistant acid phosphatase isoform-5b.