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. Author manuscript; available in PMC: 2019 May 1.
Published in final edited form as: Osteoporos Int. 2018 Apr 7;29(5):1009–1022. doi: 10.1007/s00198-018-4507-8

Table 2.

Clinical studies of teriparatide effects

Clinical
Conditions		 Patient
Number		 Study Type Groups Follow-up
time		 Results Reference
Spine fusion 19 Retrospective

  • TPTD 20 µg daily, 2 months pre-op and 8 months post-op. After discontinue TPTD, 17.5 mg risedronate weekly

 36 months

  • Bone union rate 95% at 2 year and 3 year follow up

 Ohtori 2017 [21]
62 Retrospective

  • TPTD 20 µg 7.4 months post-op;

  • Control

 12 months

  • Bone union rate 66.7% in the TPTD group and 50% patients in the control group.

  • Incidence of screw loosening was lower in TPTD (13.4%) compared to 24.4% in the control group

 Kaliya 2017 [19]
45 Retrospective

  • TPTD 20 µg daily×5.5 months; TPTD

  • 20 µg daily×13 months;

  • BPs: risedronate 17.5 mg weekly × 3 months pre-op, 12 months post-op

 15 months

  • Bone union rate were 92% in the long-duration TPTD group, 80 % in short-duration TPTD group and 70% in the BPs group.

  • Average duration for bone union 7.5 months in the long- duration TPTD group, 8.5 months in the short-duration TPTD group and 10.0 months in the BPs group

 Ohtori 2015 [20]
62 Retrospective

  • TPTD 20 µg daily or TPTD 56.5 µg weekly×minimum 1 months pre-op;

  • Control

 N/A

  • The mean insertional torque value in the TPTD group was significantly higher than in the control group (1.28 ± 0.42 Nm versus 1.08 ± 0.52 Nm, p < 0.01).

  • No significant difference between the daily and the weekly TPTD groups with respect to mean insertional torque value (1.34 ± 0.50 Nm and 1.18 ± 0.43 Nm, respectively, p = 0.07).

  • There was negligible correlation between insertional torque and duration of preoperative TPTD treatment (r2= 0.05, p < 0.01)

 Inoue 2014 [22]
47 Prospective

  • TPTD 20 µg daily × 3months post-op cycling with alendronate 91.37 mg weekly × 3 months for 12 months;

  • BPs: alendronate 91.37 mg weekly × 12 months

 24 months

  • Time to fusion was 6.0 ± 4.8 months in the TPTD group and 10.4 ± 7.2 months in the BPs group.

  • The bone fusion rate in the TPTD group was higher than that in the bisphosphonate group at 6 months but no difference at 12 and 24 months

 Cho 2017 [26]
66 Prospective

  • TPTD 56.5 µg weekly × 6 months post-op;

  • Control

 6 months

  • Bone fusion rate is higher in TPTD (69.0%) than control group (35.1%)

 Ebata 2017 [23]
58 Prospective

  • TPTD 20 µg daily × 3 months pre-op and 21 months post-op;

  • BPs: alendronate 5 mg daily or risedronate 2.5 mg daily × 3 months pre-op and 21 months post-op

 24 months

  • Bone fusion rate was significantly higher in the TPTD group (89%) than in the BPs group (77%)

 Seki 2017 [25]
62 Prospective

  • TPTD 20 µg daily × 2 months pre-op and 10 months post-op;

  • BPs: risedronate 2.5 mg daily × 2 months pre-op and 10 months post-op

 12 months

  • Incidence of pedicle screw loosening in the TPTD group (7%–13%) was significantly lower than that in the risedronate group (13%−26%) or control group (15%–25%) (P < 0.05).

  • Incidence of pedicle screw loosening in the risedronate group was not significantly different from that in the control group (P > 0.05)

 Ohtori 2013 [28]
57 Prospective

  • TPTD 20 µg daily × 2 months pre-op and 8 months post-op;

  • BPs: risedronate 17.5 mg daily × 2 months pre-op and 8 months post-op

 12 months

  • Fusion rate was 82% in the TPTD group and 68% in the bisphosphonate group (P < 0.05).

  • Time to fusion was 8 months in the TPTD group and 10 months in the bisphosphonate group (P < 0.05)

 Ohtori 2012 [24]
Osteonecrosis of jaw (ONJ) 17 Case control

  • TPTD 20 µg daily × 1.8 months + BMP;

  • BMP;

  • Control

 6 months

  • In all groups, the ONJ lesions were healed and new bone formation was detected in the cone beam CT images. The regeneration ratio was significantly greater in the group TPTD+BMP than in the BMP and control groups. Local application of BMP alone also had a beneficial effect on bone regeneration but was not more significant than control

 Jung 2017 [34]
24 Retrospective

  • TPTD 20 µg daily × 6 months;

  • Control

 6 months

  • The clinical improvement of ONJ was statistically better in the TPTD group after the 6-month treatment (60% in control group vs. 62.5% in TPTD group p < 0.05)

 Kim 2014 [36]
40 Prospective

  • TPTD 20 µg daily × 4 months

 12 months Bashutski 2010
Arthroplasty 40 Retrospective

  • TPTD 56.5 µg weekly × 12 months;

  • Control: cementless total knee replacement

 12 months

  • BMD (BMC/TV) was significant higher in TPTD group in the medial sites, but not lateral sites at 6, 9, and 12 months follow up

 Kaneko 2016 [45]
92 Retrospective

  • TPTD (non-specified dose) daily for 1 year;

  • Control in cementless hemiarthroplasty in femoral neck fractures

 3 months

  • The subsidence of the femoral stem tended to be significantly decreased in the TPTD group at 6 and 12 weeks post-operatively (p = 0.003 and p = 0.008, respectively)

 Huang 2016 [46]
48 Prospective

  • TPTD 20 µg × 12 months;

  • Alendronate 35 mg weekly × 12 months;

  • Control; cementless in total hip replacement

 12 months

  • TPTD had an equal effect to alendronate in the prevention of periprosthetic BMD loss, but was superior to alendronate with regards to lumbar BMD improvement

 Kobayashi 2016 [47]
50 Prospective

  • TPTD 20 µg daily for 2 months post-op;

  • Control in cemented total knee replacement

 24 months

  • Median maximal total point motion from 12 to 24 months was similar in the 2 groups (TPTD: 0.14 mm vs. control: 0.13 mm)

 Ledin 2017 [48]
Fracture healing 102 Case control

  • TPTD 40 µg daily × 2 months;

  • TPTD 20 µg daily × 2 months;

  • Control

 42 weeks

  • Median time to fracture healing significantly shorter in the TPTD 20µg/day group (7.4 weeks), but not in the TPTD 40 µg/day group (8.8 weeks) compared with the placebo group (9.1 weeks) (p = 0.015)

 Aspenberg 2010 [62]
27 Case control

  • TPTD 40 µg daily × 2 months;

  • TPTD 20 µg daily × 2 months;

  • Control

 5 weeks

  • Significant dose dependent improvement in radiographic callus assessment score (p < 0.001)

 Aspenberg 2010 [63]
65 Case control

  • TPTD 100 µg daily × 24 months;

  • Control

 24 months

  • Mean time to fracture healing significantly shorter in treatment group (7.8 weeks) versus control group (12.6 weeks; p < 0.001)

  • Visual analog scale score for pain and

  • the Timed ‘‘Up and Go’’ test improved in the treatment group versus the control group (p < 0.001)

 Peichl 2011 [64]
Atypical femoral fracture (AFF) 15 Case series

  • TPTD 20 µg daily × 12 months

 12 months

  • TPTD associated with improvement in bone turnover

 Miller 2015 [75]
6 Retrospective

  • TPTD 20 µg daily > 3 months + operation

 24 months

  • Union completed radiologically median 5.4 months and clinically 5.7 months after the medication, respectively. Callus appeared abundantly showing median 1.4 of fracture healing response post-operatively

 Kim 2016 [82]
35 Retrospective

  • TPTD 20 µg daily or TPTD 56.5 µg (duration N/A)

 >12 months

  • In subanalyses for all AFFs treated surgically, mean (± standard deviation) time to fracture healing significantly better in the TPTD group (5.4 ± 1.5 months) than in non- TPTD group (8.6 ± 4.7 months; P = 0.012), and frequency of delayed healing or non-union significantly lower in the TPTD group than in the non-TPTD group (P = 0.014)

 Miyakoshi 2015 [71]
14 Prospective

  • TPTD 20 µg daily × 24 months

 24 months

  • No significant effect of TPTD on hip BMD, MS/BS or TBS and no

  • consistent effect on fracture healing

 Watts 2017 [68]
14 Prospective

  • TPTD 20 µg daily × 6 months;

  • Control

 6 months

  • TPTD group was associated with 2-3-fold increase in bone remodeling markers (p = 0.01) and fracture healing. At the distal radius, the proportion of less densely mineralized bone increased by 29.5% (p = 0.01), and the proportion of older, more densely mineralized bone decreased by 16.2% (p = 0.03). Similar observations were made at the distal tibia

 Chiang 2013 [72]
Non-union 3 Case Series

  • TPTD 20 µg daily × 3 months (2) & 9 months (1) following non-union diagnosis

 3–9 months

  • All patients obtained union of femur fracture; no adverse events related to TPTD use were noted

 Lee 2012 [69]
1 Case Report

  • TPTD 20 µg daily × 8 months following non-union diagnosis

 12 months

  • Radiographic evidence of complete union 4 months after treatment discontinuation

 Xiaofeng 2017 [70]
1 Case Report

  • TPTD 20 µg daily + revision surgery in setting of humeral non-union secondary to periprosthetic fracture

 12 months

  • Radiographic evidence of complete fracture healing 1 year post-operatively

 Emanuele 2017 [76]
1 Case Report

  • TPTD 20 µg daily × 3 months + conservative treatment in setting of type III odontoid process fracture

 6 months

  • 3 mo CT revealed partial fracture healing and near complete recalcification of fracture gap

  • 6 mo CT revealed complete fracture healing

 Bednar 2013 [77]
Stress fracture 2 Case Series

  • TPTD (non-specified dose) daily × 1 month in setting of metatarsal stress fracture

 1 month

  • 1 mo radiographs revealed bony callus and new bone formation in both patients

 Raghavan 2012 [79]
1 Case Report

  • TPTD 20 µg daily × months 1–5 and 7–16 following stress fractures in setting of hypophosphatasia

 24 months

  • Radiographic evidence of fracture repair 2–4 months after treatment onset. Hypophosphatasemia and hypophosphatemia corrected

 Whyte 2007 [80]

Abbreviations: BMC, bone mineral content; BMD, bone mineral density; BPs: bisphosphonates; BS, bone surface; MS, mineral surface; TBS, trabecular bone score; TPTD, teriparatide; TV, total volume; AFFs: Atypical femoral fractures; BMP: bone morphogenetic protein; CT: computed tomography; ONJ: osteonecrosis of jaw