International Journal of Research in Orthopaedics | May-June 2024 | Vol 10 | Issue 3 Page 704
International Journal of Research in Orthopaedics
Srivastava S et al. Int J Res Orthop. 2024 May;10(3):704-710
http://www.ijoro.org
Review Article
Revealing the therapeutic potential of teriparatide: a review
Sushant Srivastava
1
*, Arvind Kumar
1
, Vishal Kundnani
2,3
, Amit Ajgaonkar
4,5
INTRODUCTION
Teriparatide, approved by FDA, EMA and CDSCO as
second- or third-line treatment after first-line therapy with
Bisphosphonates, is an osteoanabolic drug indicated for
treating osteoporosis in patients at high risk of fracture,
including postmenopausal women, men with primary or
hypogonadal osteoporosis, as well as both men and women
with osteoporosis linked with persistent systemic
glucocorticoid therapy.
1-4
It stimulates the function,
differentiation, and survival of osteoblasts and osteoclasts,
as well as helps improve the BMD and prevent fractures in
individuals with osteoporosis.
5,6
Its ability to enhance
various processes in forming endochondral bone and
constructing the primary callus can aid in healing
fractures.
7
The pharmacology of teriparatide has been
illustrated below in (Figure 1).
A growing body of evidence supports the use of
teriparatide for off-label indications such as osteonecrosis
of jaws and chronic periodontitis, improving fracture
healing rates
and treating osteogenesis imperfect in men
and women.
8-10
As the efficacy of teriparatide for these
indications has yet to be fully established, it is apparent
that for these indications, teriparatide should only be
ABSTRACT
Teriparatide is an FDA-approved medication for osteoporosis that presents promising results in treating various
musculoskeletal conditions. It helps in improving the bone mineral density and preventing fractures in individuals with
osteoporosis. Its effectiveness in treating non-union and delayed union fractures, atypical femoral fractures, and spinal
fusion procedures makes it valuable in improving bone healing and reducing complications. Teriparatide also improves
bone density and strength in individuals with osteogenesis imperfecta, helps prevent and treat hypocalcaemia post-
thyroidectomy, and helps in the management of hypoparathyroidism. In MRONJ, teriparatide improves lesion
resolution and reduces bony defects. Furthermore, it potentially prevents bone metastasis in cancer patients without
stimulating tumour growth. Nevertheless, teriparatide may cause short-term side effects like nausea and long-term
concerns pertaining to the risk of osteosarcoma. Recent European alliance of associations for rheumatology guidelines
have highlighted teriparatide's superior effectiveness in achieving bone mineral density thresholds and reducing fracture
risks. Further clinical trials are necessary to determine optimal dosages and treatment durations of teriparatide. The off-
label use of teriparatide should be considered only under the guidance of a healthcare professional when standard
options are unavailable or inadequate.
Keywords: Teriparatide off-label treatment, Fractures, Cancer, Medication-related osteonecrosis
1
Department of Orthopaedics, MGM Medical College, Mata Gujri University, Kishanganj, Bihar, India
2
Department of Orthopaedics, Lilavati Hospital, Mumbai, Maharashtra, India
3
Department of Orthopaedics, Bombay Hospital, Mumbai, Maharashtra, India
4
Department of Orthopaedics, BDBA Hospital
,
Kandivali, Mumbai, Maharashtra, India
5
Zenith Hospital, Malad,
Mumbai, Maharashtra, India
Received: 14 October 2023
Accepted: 15 March 2024
*Correspondence:
Dr. Sushant Srivastava,
E-mail: sushant391992@yahoo.co.in
Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under
the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial
use, distribution, and reproduction in any medium, provided the original work is properly cited.
DOI: https://dx.doi.org/10.18203/issn.2455-4510.IntJResOrthop20241128
Srivastava S et al. Int J Res Orthop. 2024 May;10(3):704-710
International Journal of Research in Orthopaedics | May-June 2024 | Vol 10 | Issue 3 Page 705
considered when other treatment options have been
exhausted, and the potential benefits outweigh the risks.
We aimed to present a review of the use of teriparatide to
explore its potential as a treatment option for
musculoskeletal conditions beyond osteoporosis and the
potential for expanding the understanding of its
mechanism of action and therapeutic applications. We
believe that a review of the available literature can provide
insights into the safety and efficacy of teriparatide for off-
label use, guide clinical decision-making, and identify
potential avenues for future research.
Figure 1: Pharmacology of teriparatide.
1
TERIPARATIDE: BEYOND OSTEOPOROSIS
The utilization of teriparatide for a medical condition or
purpose that has not received approval from the local
regulatory bodies is termed as its off-label indication.
2,11
The (Figure 2) depicts the potential uses of teriparatide.
Faster fracture healing
Teriparatide is a potential option for accelerating fracture
healing, showing promising results in clinical studies. One
such randomized controlled study compared the effects of
bisphosphonate and weekly teriparatide therapy on 43
patients with fresh spinal vertebral compression fractures
in osteoporotic patients, where the teriparatide group
(N=19) showed a significantly higher fracture-healing rate
(73%) than the bisphosphonate group (N=24) (45%) at
week 12 (p<0.05), with a significantly reduced mean time
of fracture-healing of 2.8 months in the teriparatide group
and 3.9 months for the bisphosphonate group (p<0.05).
12
Similarly, in a retrospective cohort study that compared
three groups of patients with intertrochanteric fractures,
i.e. patients who had not received any osteoporosis
medication prior to fracture and postoperatively received
only calcium and vitamin D (Group 1) (N=83), patients not
on any osteoporosis medication prior to fracture, but
received teriparatide and calcium and vitamin D
postoperatively (Group 2) (N=47), patients on alendronate
prior to fracture and post fracture received teriparatide,
calcium and Vitamin D (Group 3) (N=59).
A significantly shorter time-to-union; mean, 13.6, 12.3,
and 10.6 weeks, respectively (p = 0.002) was noted in the
teriparatide-treated group.
9
This action of teriparatide can
be attributed to its ability to induce osteoblastic and
chondroblastic progenitor cells, promoting callus
formation and remodeling. Improved bone matrix protein
synthesis and stimulation of the Wnt/β-catenin signalling
pathway resulting in increased formation of types II and X
collagen, contribute to fracture healing.
13,14
Figure 2: The potential uses of teriparatide.
Nonunion fracture
According to the US FDA, nonunion of fracture is defined
as “a fracture that persists for a minimum of 9 months
without signs of healing for three months”.
15
But some
studies consider any disturbance of routine healing as a
nonunion. Nonunion fractures may require surgical
intervention to promote bone healing and restore
function.
16
Chintamaneni et al reported a case of a 67-year-
old male who sustained a fracture of the body of the
sternum which subsequently failed to heal, resulting in a
painful atrophic nonunion.
An empiric trial of 20 μg/day of teriparatide showed
significant healing of the nonunion within three months
and complete healing and symptomatic resolution after
nine months.
17
In another similar case, a 78-year-old
woman with osteoporosis and a sternal nonunion after a
blunt chest trauma was treated with teriparatide, resulting
in complete nonunion healing within six months. The
follow-up imaging showed improved BMD and complete
Srivastava S et al. Int J Res Orthop. 2024 May;10(3):704-710
International Journal of Research in Orthopaedics | May-June 2024 | Vol 10 | Issue 3 Page 706
fracture healing.
18
Thus, these case reports provide
evidence for the beneficial effect of teriparatide on
nonunion. However, more extensive studies are required
to prove this effect conclusively.
Delayed union fracture
Delayed unions generally refer to fractures that exhibit a
lack of healing progress within a reasonable time frame (no
radiographic evidence of healing after 3-6 months
following the initial injury) for the specific fracture type
and patient characteristics.
19
However, to overcome the delayed union, teriparatide is a
promising intervention to enhance fracture healing, as is
evident from the following retrospective study of 20
patients with unconsolidated fractures treated with
teriparatide for 6 months showing positive radiographic
indications of bone callus improvement in 15% of cases
after 1 month of therapy, with 80% displaying healing
progression at 3 months, and 10% achieving complete
healing. By the 6-month mark, 85% of patients with
delayed or nonunion fractures had experienced healing
with no significant side effects.
20
Similarly, in a 64-year-old woman with a periprosthetic
humeral fracture who underwent surgical plating and
cerclage reported persistent pain after six months and was
diagnosed as a delayed union. Administration of
teriparatide along with vitamin D and calcium resulted in
callus formation and healing in the next six months.
11
Thus, teriparatide could be a promising treatment for
delayed union fractures by promoting bone induction and
accelerating the healing process.
Atypical femoral fracture
Atypical femoral fracture (AFF) is a rare type of femur
fracture that occurs spontaneously, without significant
trauma, in patients taking certain medications for
osteoporosis, such as bisphosphonates, for an extended
period.
21
The Fracture Improvement with Teriparatide
(Fix-IT) study compared the effectiveness of immediate
therapy with teriparatide to delayed therapy for six months
in promoting fracture healing after an AFF.
The immediate therapy group had a trend for superior
healing with the composite score and lesser declines in
BMD at the 1/3 distal radius after 12 months.
22
According
to a report of a task force of the ASBMR, teriparatide may
be considered as a potential treatment option for patients
with stress fractures or subtrochanteric/femoral shaft
fractures when conventional therapies are ineffective,
though the evidence supporting its efficacy remains
limited due to the rarity of these fractures and ethical
constraints on controlled trials. It is suggested particularly
for cases showing slow healing progress after surgical
intervention.
23
reports suggest teriparatide may effectively
promote bone healing and bone-forming ability in patients
with AFF.
Spinal fusion
Spinal fusion is defined as a surgical procedure used to
rectify problems with small bones of the spine
(vertebrae).
24
A meta-analysis of 771 patients across 12
studies found that teriparatide significantly increased
lumbar spinal fusion rates by 2.15-fold (OR 2.15, 95%CI
1.56–2.97, p<0.00001) compared to non-teriparatide
treatment. The treatment effect of teriparatide had
significantly reduced subsequent vertebral fractures (OR
0.16, 95%CI 0.06-0.41, p=0.0002), sagittal malalignment
(MD-3.85, 95%CI: 6.49 to 1.21, p=0.004), limb visual
analogue score (VAS) (MD 0.36, 95%CI 0.64 to 0.09,
p=0.008), and spinal VAS (MD 0.24, 95%CI 0.44 to 0.04,
p=0.02) compared to the non-teriparatide group.
25
This
suggests teriparatide may be an effective treatment option
for promoting bone union and reducing complications in
patients with osteoporosis undergoing spinal fusion
procedures.
Osteogenesis imperfecta
Osteogenesis imperfecta (OI) is a rare hereditary condition
that makes bones brittle and prone to breaking even under
light stress or damage. The classical type of OI is caused
by gene mutations that produce type 1 collagen, reducing
bone density and strength.
26
In an interventional study,
thirteen postmenopausal women with OI (type I) who
experienced new vertebral fractures during neridronate
treatment were treated with teriparatide for 18 months.
Teriparatide therapy significantly increased lumbar spine
BMD (p=0.001), bone formation and resorption marker
along with the Wnt inhibitors serum dickkopf-1 (DKK-1)
levels, indicating a normal osteoblastic response.
27
Teriparatide, as demonstrated above, has a significant
anabolic response, increases BMD and strength, aiding in
the treatment of this rare genetic condition.
Post-thyroidectomy hypocalcemia
Hypocalcemia is a commonly observed electrolyte
imbalance in clinical practice, often stemming from a
diverse array of underlying medical conditions frequently
encountered in both surgical and medical services.
28
After
thyroidectomy, hypocalcemia can be temporary (6-12
months) or permanent (>12 months). Studies have reported
incidence rates of temporary hypocalcemia from 43% to
68%. While the risk of persistent hypocalcemia ranged
from 1.6% to as high as 5%.
29-31
Teriparatide acetate has shown promise in rapidly
increasing calcium levels in these patients.
32
The Primary
prevention of post thyroidectomy hypocalcemia
(TYPHOS) trial randomized 26 patients with low intact
parathyroid hormone levels after thyroidectomy to receive
either 20 μg of teriparatide subcutaneously every 12 hours
or standard care.
Srivastava S et al. Int J Res Orthop. 2024 May;10(3):704-710
International Journal of Research in Orthopaedics | May-June 2024 | Vol 10 | Issue 3 Page 707
The treatment group had a significantly lower incidence of
hypocalcemia (3/13) compared to the control group
(11/13) and a shorter median hospital stay (2 days vs. 3
days). After 1-month of follow-up, more patients in the
treatment group had discontinued calcium carbonate
supplements.
33
These findings suggest that teriparatide
may prevent postoperative hypocalcemia, shorten
hospitalization, and reduce the need for calcium and
vitamin D supplementation in high-risk patients
undergoing thyroid surgery.
Hypoparathyroidism
A deficiency of parathyroid hormone, known as
hypoparathyroidism, leads to the development of
hypocalcemia, hyperphosphatemia, and increased
neuromuscular irritability.
34
Hypoparathyroidism lacks
standard hormone replacement therapy, and conventional
treatments may not fully address complications like
hyperphosphatemia, peripheral calcification, kidney
stones, and bone disease.
35
Therefore, teriparatide has been
considered as a potential treatment option to treat the same.
In a 3-year randomized trial involving 27 patients with
hypoparathyroidism, twice-daily teriparatide was found to
effectively maintain normal serum calcium levels without
hypercalciuria, providing a safe alternative to calcitriol
therapy.
36
In cases of chronic hypoparathyroidism, ASBMR panel
recommended conventional therapy using calcium and
active vitamin D metabolites as the first-line treatment.
This is considered a weak recommendation supported by
low-quality evidence. However, the panel suggested
considering the use of parathyroid hormone as an
alternative treatment option in patients whose chronic
hypoparathyroidism is inadequately controlled by
conventional treatment, defined by symptomatic
hypocalcemia, hyperphosphatemia, renal insufficiency,
hypercalciuria, or reduced quality of life.
Parathyroid hormone therapy may also benefit individuals
with compliance issues, malabsorption, intolerance to high
calcium and active vitamin D doses, or those requiring
substantial conventional therapy (e.g., calcium >2 g/day or
active vitamin D >2 μg/day).
37
Medication-related osteonecrosis of the jaw
American association of oral and maxillofacial surgeons
(AAOMS) states that MRONJ is a rare but severe adverse
drug reaction associated with bisphosphonates,
denosumab and romosozumab.
38
Medication-related
osteonecrosis of the jaw (MRONJ) is most frequently
observed while treating osteoporosis, malignancy-
associated metabolic bone lesions, and Paget’s disease,
with an estimated incidence of 0.001% to 0.01% in the
osteoporosis patient population.
38,39
Santos Ferreira et al.
analyzed the teriparatide therapy in combination with
antibiotic therapy being effective in treating MRONJ
based on a comprehensive analysis of 111 cases from 26
publications.
According to Poisson regression analysis, those with
MRONJ stage 1 had a 1.21-fold higher chance than those
with stage 3 (CI=1.02-1.43 p<0.023), and those who
received teriparatide in conjunction with another
therapeutic modality had a 1.21-fold higher chance of
having fully resolved osteonecrosis than those who
received teriparatide alone (CI=1.40-1.39 p<0.010).
40
In a double-blind, randomized trial, 34 participants with
MRONJ were given either teriparatide or placebo along
with the standard of care for eight weeks. Teriparatide
group had a higher rate of MRONJ lesion resolution; odds
ratio (OR) 0.15 vs. 0.40, p=0.013 and reduced bony defects
at 52 weeks (OR 8.1, p=0.017) compared to the placebo.
41
This evidence suggests teriparatide may be a beneficial
treatment for MRONJ compared to standard conservative
management.
Cancers
Teriparatide has been the subject of two experimental
studies investigating its potential effects on tumour growth
in a mouse lung cancer model with bone metastasis and in
murine as well as human breast cancer models. In the first
trial, teriparatide injections at intermittent intervals
reduced the amount of bone around the metastatic lesions
while preventing the formation of metastatic bone tumours
in mice.
42
Another study demonstrated that anabolic
teriparatide treatment could modify the bone
microenvironment and minimize the incidence of skeletal
metastasis in patients with advanced breast cancer.
43
Here,
both studies imply that teriparatide therapy may
potentially prevent bone metastasis in cancer patients,
particularly those with advanced breast cancer, without
boosting tumour growth.
Side effects and safety considerations
Side effects and safety considerations of teriparatide are
listed in (Table 1).
Table 1: Side effects and safety considerations of teriparatide.
44,45
Parameters
Recommended
dose
Treatment
duration
Continued.
Srivastava S et al. Int J Res Orthop. 2024 May;10(3):704-710
International Journal of Research in Orthopaedics | May-June 2024 | Vol 10 | Issue 3 Page 708
Parameters
Contraindications
Side effects
EUROPEAN ALLIANCE OF ASSOCIATIONS FOR
RHEUMATOLOGY (EULAR) GUIDELINES 2023
In the recent recommendation of the EULAR guidelines,
the “Proportion of patients reaching the bone mineral
density (BMD) surrogate threshold effect (STE) with
bisphosphonates, denosumab and teriparatide”
study
report was presented. Following were the key takeaways
noted; Faster Achievement of BMD Thresholds: Patients
on teriparatide achieved the BMD STE faster compared to
bisphosphonates and denosumab.
46
This was particularly
evident at the two-year mark. The study reported a
statistically significant difference in reaching BMD STEs
between teriparatide and bisphosphonates at two years
(log-rank p<0.001). Risk Reduction: Teriparatide was
associated with significant risk reduction for vertebral
fractures, with a BMD increase of 4.6%, resulting in >50%
risk reduction compared to other treatments. Long-term
Success: While a smaller proportion of patients on
teriparatide reached BMD STEs at two years compared to
denosumab, teriparatide demonstrated comparable
effectiveness at two years and surpassed bisphosphonates
at this milestone. Additionally, nearly all subjects achieved
STEs after six years of follow-up with teriparatide. These
takeaways and the bar graph displayed in Figure 3
comparing bisphosphonates, denosumab, and teriparatide
in terms of patient proportions reaching specific STEs over
time highlight the superior effect of teriparatide in this
study in terms of achieving BMD thresholds and reducing
fracture risk, particularly in comparison to
bisphosphonates and denosumab.
Figure 3: Bar graph indicating proportion of patients
with increasing BMD at 24 months above STEs.
46
CONCLUSION
Numerous studies and case reports have examined the off-
label use of teriparatide for treating conditions such as
atypical femoral fractures, osteogenesis imperfecta, and
nonunion fractures, indicating its potential effectiveness.
However, further carefully planned clinical trials are
required to validate these results and establish the optimum
teriparatide dosage and duration of therapy for these
patient groups. It should be emphasized that the off-label
use of teriparatide is only appropriate when standard
treatment options are inadequate or unavailable and must
be administered under the close supervision of a competent
healthcare professional.
Funding: No funding sources
Conflict of interest: None declared
Ethical approval: Not required
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Cite this article as:
Srivastava
S, Kumar A,
Kundnani
V, Ajgaonkar A
. Revealing the therapeutic
potential of teriparatide: a review. Int J Res Orthop
2024;10:704-10.